Ex Parte Cooper et alDownload PDFPatent Trials and Appeals BoardMay 22, 201914052088 - (D) (P.T.A.B. May. 22, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/052,088 10/11/2013 38473 7590 05/24/2019 ELMORE PATENT LAW GROUP, PC 484 Groton Road Westford, MA 01886 FIRST NAMED INVENTOR Eugene R. Cooper 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 4180.3000 US2 8456 EXAMINER VU, JAKE MINH ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 05/24/2019 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): docketing@elmorepatents.com pair_elmore@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte EUGENE R. COOPER, EV AN R. THOMPSON, and ELLIOT R. THOMPSON (APPLICANT: Thompson Cooper Laboratories, LLC) Appeal2019-000006 Application 14/052,088 1 Technology Center 1600 Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal2 under 35 U.S.C. § 134(a) involves claims 1, 6-8, 10-14, 16, 17, and 19-27 (Br. 3). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify "Thompson Cooper Laboratories, LLC" as the real party in interest (Appellants' April 1 7, 2018 Appeal Brief (Br.) 1 ). 2 This Appeal is related to co-pending Appeal 2019-000003, Application 14/026,342 (see generally Br. 1) Appeal2019-000006 Application 14/052,088 STATEMENT OF THE CASE Appellants' disclosure "relates to the field of topical treatments for infections such as nail infections, particularly fungal infections of the nail commonly referred to as onychomycosis. Particularly, the invention relates to novel compositions containing peroxide for the treatment of such nail infections and other infections" (Spec. 3 1: 12-15). Claims 1, 7, 13, 19, 22, 23, 26, and 27 are representative and reproduced below: 1. A method of treating a nail infection, comprising the steps of (a) applying to the infected nail a film of a composition consisting essentially of at least about 3 % by weight hydrogen peroxide, from 50% to 95% by weight highly volatile solvent, a thickening agent and water; and (b) allowing the film to dry. (Br. 21.) (Id.) (Id.) 7. The method of claim 1, wherein the highly volatile solvent is selected from the group consisting of methanol, ethanol, n- propanol, isopropanol and combinations thereof. 13. The method of claim 1, wherein the anti-infective composition is about 6% to 15% hydrogen peroxide by weight. 19. The method of claim 1, wherein the infection is fungal onychomycosis. (Id. at 22.) (Id.) 22. The method of claim 1, wherein the thickening agent is a polymer. 23. The method of claim 7, wherein the alcohol is ethanol. (Id.) 3 Appellants' October 11, 2013 Specification. 2 Appeal2019-000006 Application 14/052,088 26. The method of claim 1, wherein said applying is limited to the nail. (Id. at 23.) (Id.) 27. The method of claim 1, wherein the composition consists of, by weight, 3% hydrogen peroxide, 3% water; 93.5% isopropanol and 0.5% hydroxypropylcellulose. Grounds of rejection before this Panel for review: I. Claims 1, 6-8, 10-14, 16, 17, and 19-27 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Wright '349, 4 Wright '334, 5 Drysdale, 6 Tichy, 7 and Omidbakhsh. 8 II. Claims 1, 6-8, 10-14, 16, 1 7, and 19-21 stand rejected under 3 5 U.S.C. § I03(a) as unpatentable over the combination of Wright '349, Wright '334, Drysdale, Tichy, and Omidbakhsh. Rejection II is cumulative to Rejection I. Therefore, we vacate and will not further discuss cumulative Rejection II. ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 4 Wright, US 2001/0053349 Al, published Dec. 20, 2001. 5 Wright, US 60/180,334, filed Feb. 4, 2000. 6 R. Drysdale, Hydrogen Peroxide for Foot Fungus, http://ezinearticles.com/?Hydrogen-Peroxide-for-Foot-Fungus&id=228019 (2006), last assessed 7/21/2014. 7 Tichy et al., US 2007/0059255 Al, published Mar. 15, 2007. 8 Omidbakhsh, US 2005/0255172 Al, published Nov. 17, 2005. 3 Appeal2019-000006 Application 14/052,088 FACTUAL FINDINGS (FF) FF 1. Wright '349 discloses "a method of reducing fungal nail infection ... , such as onychomycosis ... comprising [applying a] gel soak [composition] ... on to artificial nails" (Ans. 9 3 (citing Wright '349 Abstract and ,r 1 ). FF 2. Wright '349 "provides an anti-septic composition/sanitizing solution/cosmeceutical" that "includes a drying compound and a sanitizer" that "can be in a spray or gel soak form" (Wright '349 ,r 5; Ans. 3). FF 3. Wright '349's "artificial nail sanitizing solution has the preferred composition of 2-propanol or isopropyl alcohol and 3% hydrogen peroxide. However, while peroxide is the preferred antiseptic/sanitizer others can be utilized. Such agents must be able to possess fungistatic or bacteriostatic properties when added to the composition" (Wright '349 1, col. 2, 11. 11-16; Ans. 3--4). FF 4. Wright '349's "artificial nail sanitizing solution uses 2-propanol as the preferred drying agent, other drying agents can be used without departing from the purpose of the present invention. Examples of such drying agents are commonly known by those of skill in the art" (Wright '349 1, col. 2, 11. 17-21; Ans. 3--4). FF 5. Wright '349 provides the following reaction schemes: Formula (A): Formula (B): (USP) CH3-CHrOH + (3%) H202------, CH3-COOH + H20 + 2H (Wright '349 ,r 5; Ans. 4.) 9 Examiner's July 31, 2018 Answer. 4 Appeal2019-000006 Application 14/052,088 FF 6. Examiner finds: WRIGHT' s provision application 60/180,334 teaches the composition can be use on finger and toe nails (see pg. 1 ), wherein "peroxide is a cleaning agent for skin, it also provides oxygen to nail folds needed to inhibit fungal growth" ( see Appendix A at pg. 8), to treat a condition called on onychomycosis (see Appendix at pg. 5-7), which can be seen acrylic nail wearers (see Appendix at pg. 5), in normal tissue as in the nail bed or nail matrix (see Appendix at pg. 6), and in diabetic as a secondary infection more so than nondiabetics (see Appendix at pg. 7). (Ans. 6-7.) FF 7. Examiner relies on Drysdale to establish "that the prior art had known of using 3% hydrogen peroxide to treat fungal nail infection and allowing the composition to dry" (Ans. 4; see Drysdale (Drysdale discloses that it is "quite common to have both athlete's foot and nail fungus" and "you can choose a fungal remedy to treat both at once," wherein "[p]opular home remedies include soaking the feet in vinegar, dilute bleach, or hydrogen peroxide for foot fungus." Drysdale further discloses the "[u]se [of] a 3% solution, as ... stronger preparations are less safe and may cause skin reactions," wherein treatment "[a]pproaches include soaking in the peroxide, wiping onto the affected areas several times daily, or spraying it on and allowing it to dry," and Drysdal discloses that such treatment "is likely to produce results much faster for athletes foot fungus than for a nail infection")). FF 8. Tichy discloses: [M]ethods for treating viral infections, bacterial infections, fungal infections, and cancerous tissue. The methods include the administration of an aqueous composition that can comprise an aqueous vehicle, including water, from 0.0001 wt% to 10.0 5 Appeal2019-000006 Application 14/052,088 wt% of a peroxygen[ 10J, and optionally, an alcohol. Additionally, from 0.001 ppm to 50,000 ppm by weight of a transition metal based on the aqueous vehicle content can also be present. Alternatively or additionally, the transition metal can be in the form of a colloidal transition metal, such as colloidal silver or alloy thereof (Tichy, Abstract; see id. ,r 17 (Tichy discloses onychomycosis as an exemplary fungal infection); Ans. 4; see Br. 22 (a fungal infection within the scope of Appellants' claimed invention "is fungal onychomycosis").) FF 9. Tichy disclose that "alcohol, when present, ... can be present at from 0.0001 wt % to 95 wt %" (Tichy ,r 20; see id. at ,r,r 22-23 (Tichy discloses that the term alcohol encompasses ethanol, isopropanol, and mixtures of ethanol and methanol); Ans. 4). FF 10. Tichy discloses that when its composition is formulated "as a gel or ointment, the composition can include other excipients and fillers such [as] gelling or thickening agents," such as an acrylate copolymer or cellulose derivative (Tichy ,r 31; Ans. 4 ( citing Tichy ,r,r 14, 19, 31) (Examiner finds that "topical administration can be carried out [ one or more times daily] using gels ... wherein gel formulations typically include gelling or thickening agents, such as polymers and cellulose derivatives")). FF 11. Omidbakhsh "relates to disinfecting solutions or formulations for use on skin containing hydrogen peroxide" (Omidbakhsh ,r 2). FF 12. Omidbakhsh discloses that in order [t]o improve the rheological properties and attractiveness of the solution, the solution can further comprise at least one thickening agent compatible with hydrogen peroxide ( e.g. polyacrylic acid polymers, polysaccharides, and cellulose-based 10 Tichy discloses that "[t]he term 'peroxygen' refers to[, inter alia,] ... peroxides such as hydrogen peroxide" (Tichy ,r 9). 6 Appeal2019-000006 Application 14/052,088 polymers in a concentration of from about 0.01 to about 5% w/w of the solution, and at least one member chosen from dyes andfragrances (as are known in the art) in a concentration of from about 0.001 to about 0.5% w/w of the solution. (Omidbakhsh ,r 26; see id. ,r,r 76, 79 (Omidbakhsh discloses hydroxypropylcellulose as a thickening agent within the scope of its disclosure); Ans. 4.) ANALYSIS Rejection I: Claim 1: Appellants' method of treating a nail infection comprises "the steps of (a) applying to the infected nail a film of a composition consisting essentially of at least about 3% by weight hydrogen peroxide, from 50% to 95% by weight highly volatile solvent, a thickening agent and water; and (b) allowing the film to dry" (Br. 21 ). Tichy discloses a method of treating, inter alia, fungal infections such as fungal onychomycosis, comprising the administration of a composition comprising 0.0001 wt% to 10.0 wt% hydrogen peroxide, 0.0001 wt% to 95 wt% alcohol, water, and a thickening agent, such as an acrylate copolymer or cellulose derivative to an affected area (FF 8-1 O; see also FF 7 (Examiner relies on Drysdale to establish "that the prior art had known of using 3% hydrogen peroxide to treat fungal nail infection and allowing the composition to dry")). Further, Omidbakhsh discloses that, for a disinfecting composition for use on skin that comprises hydrogen peroxide, the rheological properties and attractiveness of the composition can be improved by the use of a thickening agent, such as hydroxypropylcellulose, in a concentration of from about 0.01 to about 5% w/w of the solution (FF 7 Appeal2019-000006 Application 14/052,088 11-12). Thus, at the time of Appellants' claimed invention, it would have been prima facie obvious to those of ordinary skill in this art to have used Omidbakhsh's hydroxypropylcellulose as the cellulose derived thickening agent in Tichy's composition. The method suggested by the combination of Tichy and Omidbakhsh comprises the administration of a composition that contains the same ingredients required by Appellants' claim 1 in concentration ranges that encompass or overlap those set forth in Appellants' claim 1 (see FF 7-12; cf Br. 21). See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) ("[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness."); see also In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997) (Overlapping ranges support a prima facie case of obviousness.). Thus, we find no error in Examiner's conclusion of obviousness (see generally Ans. 5-8). 11 In this regard, we find no error in Examiner's rationale that because the combination of Tichy, Drysdale, and Omidbakhsh set forth concentration ranges that encompass or overlap the concentration ranges set forth in Appellants' claimed invention, a person of ordinary skill in this art would have determined the optimum or workable concentrations for the ingredients through routine experimentation. See In re Aller, 220 F .2d 454, 456 (CCP A 1955) ("[W]here the general conditions of a claim are 11 Because the combination of Tichy, Drysdale, and Omidbakhsh makes obvious Appellants' claimed invention, we find it unnecessary to address Wright '349 and Wright '334. The Board may rely upon less than all the references cited by the Examiner. See In re May, 574 F.2d 1082, 1090 (CCPA 1978); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). 8 Appeal2019-000006 Application 14/052,088 disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"). For the reasons provided above, the facts on this record differ from those in Stephan, wherein our reviewing Court found "[ m ]issing from the Board's analysis ... an explanation as to why it would have been routine optimization to arrive at the claimed invention." See In re Stephan Co., 868 F.3d 1342, 1346 (Fed. Cir. 2017); cf Br. 7. Drysdale expressly discloses that it is "quite common to have both athlete's foot and nail fungus" and "you can choose a fungal remedy to treat both at once," such as application of a composition comprising 3% hydrogen peroxide (FF 7). Therefore, we are not persuaded by Appellants' contention that "Drysdale does not teach that hydrogen peroxide can treat a nail fungal infection" (Br. 8). Appellants contend that "Drysdale is contradicted by Shirwaikar, [ 12J" because Shirwaikar discloses that "topical medications are usually not effective against nail fungus ... because nails are too hard for external applications to penetrate" (Br. 8 ( emphasis added); see also id. at 8-10, 15). We are not persuaded. Appellants failed to identify a disclosure in Shirwaikar that identifies Drysdale' s topical treatment as one that would fall within the scope of topical treatments that are "usually not effective against nail fungus" and, thus, Appellants' contention that Shirwaikar contradicts Drysdale's express disclosure is not supported by the record (see FF 7; cf Br. 8). Similarly, we are not persuaded by Appellants' contention that 12 Shirwaikar et al., Treatment of Onychomycosis: An Update, 70 INDIAN J PHARM SCI. 710-714 (2008). 9 Appeal2019-000006 Application 14/052,088 Appellants' Exhibit D 13 contradicts Drysdale, because it discloses that "common home remedies do not effectively treat" "ringworm, which includes nail fungal infections" (Br. 8 ( citing Exhibit D); see also id. at 8- 10). Initially, we note that Appellants fail to establish that Drysdale's treatment method falls within the scope of Exhibit D's "common home remedies." Appellants further failed to establish that all nail fungal infections result in ringworm. In addition, Appellants' claim 1 does not require the effective treatment of ringworm and, thus, Appellants' contention is not commensurate in scope with Appellants' claimed invention. For the reasons discussed above, Appellants' claim 1 is prima facie obvious over the combination of Tichy, Drysdale, and Omidbakhsh (see generally supra n. 11 ). Therefore, we are not persuaded by Appellants' contention that "there would have been no motivation to substitute the purported composition of Wright for the composition of Drysdale in a method of treating nail fungus" (Br. 10 (citing Cooper Dec. 14)). We are not persuaded by Appellants' contentions relating to Tichy' s preferred embodiments or exemplified embodiments (Br. 11-12). A reference disclosure is not limited only to its preferred embodiments, but is available for all that it discloses and suggests to one of ordinary skill in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976); see also In re Susi, 440 F .2d 442, 446 n.3 (CCP A 1971) (Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or 13 Johns Hopkins Medicine publication available at http://www.hopkinsmedicine.org/healthlibrary /printv .aspx? d=85 ,p00310, last accessed Oct. 6, 2015 (see Br. 8 (Appellants' state that "Exhibit D [was] provided with the Amendment filed November 20, 2015")). 14 Declaration of Eugene R. Cooper, Ph.D., signed Jan. 29, 2015. 10 Appeal2019-000006 Application 14/052,088 non-preferred embodiments.). In this regard, we note that although Tichy may exemplify a composition comprising silver ions or colloidal silver, these ingredients are not required ingredients in Tichy' s composition (see FF 8). Therefore, we are not persuaded by Appellants' contention that because Tichy exemplifies compositions comprising "silver ions or colloidal silver, [Tichy] teach[ es] away from compositions of the instant claims which have only hydrogen peroxide as an active agent" (Br. 12). As discussed above, Tichy discloses hydrogen peroxide compositions that fall within the scope of the compositions set forth in Appellants' claims and are useful in treating fungal infections (FF 8-10). Drysdale discloses treating nail fungus with hydrogen peroxide compositions (FF 7). Omidbakhsh is relied upon to establish that it would have been prima facie obvious to use carboxymethylcellulose as the thickening agent in hydrogen peroxide compositions, such as those suggested by Tichy (FF 11-12). Therefore, we are not persuaded by Appellants' contention that Omidbakhsh teaches "away from the compositions recited in ... Appellants' claims," because it suggests a composition comprising cyclic carboxylic acid or a surfactant that are not required by Appellants' claimed invention or Tichy (Br. 12). As discussed above Tichy discloses a method of (a) treating a fungal infection, such as onychomycosis, which falls within the scope of Appellants' claimed invention, (b) with a composition that falls within the scope of Appellants' claimed invention (FF 8-10). Therefore, notwithstanding Appellants' contention to the contrary, we find that Tichy is the closest prior art on this record ( cf Br. 13 ("the instant claims are drawn to a method of treating a nail infection, not to a composition per se, the 11 Appeal2019-000006 Application 14/052,088 closest art is Drysdale")). Therefore we are not persuaded by Appellants' contention that their Specification "establishes that the method of the instant claims provides an unexpected benefit compared to the use of an aqueous hydrogen peroxide solution as disclosed by Drysdale" (Br. 12; see also id. at 12-13). Claims 13 and 14: As Appellants explain, "[c]laim 13 depends from claim 1 and limits the hydrogen peroxide concentration to 6 to 15% by weight. Claim 14 depends from claim 13 and further limits the hydrogen peroxide concentration to 9 to 12% by weight" (Br. 16). As Appellants' recognize, these hydrogen peroxide ranges overlap the hydrogen peroxide range set forth by Tichy (see id.; see also FF 8-15). For the reasons set forth above, we are not persuaded by Appellants' contention that "the meaning of the peroxygen concentration range is unclear" (Br. 16). In addition, Tichy expressly includes hydrogen peroxide in its definition of a peroxygen (supra n. 10). Therefore, we are not persuaded by Appellants' contention that "[t]here is nothing in Tichy ... that would motivate one of skill in the art to select hydrogen peroxide from the broad description of peroxygen compounds and a concentration as recited in claims 13 and 14 from the concentration range taught by this reference" (Br. 16-17). Appellants' non- persuasive contention regarding the overlapping concentration was discussed above. With respect to Appellants' contention regarding the selection of hydrogen peroxide as Tichy's peroxygen compound, we find that "[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put into the last opening in a 12 Appeal2019-000006 Application 14/052,088 jig-saw puzzle. It is not invention." Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945). To be complete, we are not persuaded by Appellants' contention regarding Tichy' s preferred or exemplified embodiments. See Br. 10; cf In re Lamberti, 545 F.2d at 750; see also In re Susi, 440 F .2d at 446 n.3 Claim 22: Having found no error in the rejection of Appellants' claim 1 over the combination of Tichy, Drysdale, and Omidbakhsh, we are not persuaded by Appellants' contention that Appellants' claim 22 is "not obvious over the cited references for reasons set forth ... for claim 1" (Br. 18). Claim 23: Appellants contend that claim 23 depends "from claim 7 and [is] not obvious over the cited references for the reasons set forth for claim 7" (Br. 19). Appellants do not, however, provide separate argument for Appellants' claim 7. Therefore, having found no error in the rejection of Appellants' claim 1 over the combination of Tichy, Drysdale, and Omidbakhsh, we are not persuaded by Appellants' contention regarding Appellants' claim 23. Claim 26: Having found no error in the rejection of Appellants' claim 1 over the combination of Tichy, Drysdale, and Omidbakhsh, we are not persuaded by Appellants' contention that Appellants' claim 26 "is ... not obvious over the cited references for the same reasons as [ discussed for Appellants'] claim 1" (Br. 19). As discussed above, the combination of Tichy, Drysdale, and 13 Appeal2019-000006 Application 14/052,088 Omidbakhsh suggests a method of treating fungal infection, such as fungal onychomycosis, by applying a composition within the scope of the composition set forth in Appellants' claimed invention to an area in need of such treatment, such as the fungal infection of a nail, as disclosed by Drysdale (see FF 7-12). Therefore, we are not persuaded by Appellants' contention that "none of the cited references disclose a method of applying a composition as set forth in [Appellants'] claim 1, wherein said applying is limited to the nail," i.e., an area in need of treatment (Br. 19). Claim 27: Having found no error in the rejection of Appellants' claim 1 over the combination of Tichy, Drysdale, and Omidbakhsh, we are not persuaded by Appellants' contention that Appellants' claim 27 "is not obvious over the cited references for the same reasons as [ set forth with respect to Appellants'] claim 1" (Br. 19). "[T]he Board [has] reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art." In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Therefore, we are not persuaded by Appellants' contention that "there is no teaching or suggestion in the cited references, either individually or in combination, of the particular composition recited in claim 27" (Br. 19). CONCLUSION Rejection I: The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claims 1, 13, 14, 22, 23, 26, and 27 under 35 U.S.C. § 103(a) as unpatentable over the 14 Appeal2019-000006 Application 14/052,088 combination of Wright '349, Wright '334, Drysdale, Tichy, and Omidbakhsh is affirmed. Claims 6-8, 10-12, 1 7, and 19-21 are not separately argued and fall with claim 1. Claim 24 is not separately argued and falls with claim 22. Claim 25 is not separately argued and falls with claim 23. Rejection II stands vacated as cumulative to Rejection I. 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 15 Copy with citationCopy as parenthetical citation