Ex Parte Ekhart et alDownload PDFPatent Trial and Appeal BoardOct 14, 201412259844 (P.T.A.B. Oct. 14, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte PETER FRANK EKHART, MARIO VAN WANDELEN, and JAN MATTHIJS JETTEN __________ Appeal 2012-005078 Application 12/259,844 Technology Center 1600 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 9 and 10.2 We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Eli Lilly and Company (App. Br. 2). 2 Claims 1–8 stand withdrawn from consideration (App. Br. 2). Appeal 2012-005078 Application 12/259,844 2 STATEMENT OF THE CASE The Specification discloses “a method for preparing a veterinary composition comprising a water-insoluble veterinarily active compound, especially a benzimidazole anthelmintic, suitable for administering to a target animal through a water distribution system for the purpose of therapeutic and prophylactic medication” (Spec. 1, ¶ 0001). Claim 9 is representative of the claims on appeal and reads as follows: 9. A suspoemulsion suitable, optionally after dilution, for administering flubendazole through a water distribution system, comprising a homogeneous suspension in water of a mixture of the flubendazole and a water-immiscible liquid, said mixture having a density between 0.85 and 1.2. Issue The Examiner has rejected claims 9 and 10 under 35 U.S.C. § 102(b) as anticipated by McLaren3 (Ans. 4–5). The issue presented is: Has the Examiner established by a preponderance of the evidence that McLaren discloses the suspoemulsion of claim 9? Findings of Fact FF1. The Examiner finds that McLaren discloses the “[a]pplication in water distribution systems of veterinary sparingly soluble benzimidazoles,” wherein the sparingly soluble benzimidazole may be flubendazole (Ans. 5 (citing McLaren at 1, ll. 25–26)). 3 McLaren et al., WO 95/23590, published Sept. 8, 1995. Appeal 2012-005078 Application 12/259,844 3 FF2. The Examiner finds that McLaren discloses the “preparation of homogeneous microsuspensions of benzimadazole in water immiscible liquid (i) mixed into water (v)” (id. (citing McLaren at 3)). FF3. The Examiner finds that McLaren discloses that an “anthelmintic for animals . . . inclusive of flubendazole . . . is suspended in a homogeneous liquid vehicle of oil & a water immiscible liquid to form a microsuspension . . . with water” (id. (citing McLaren at 3, ll. 15, 22, and the top of the page and at 5, l. 28–6, l. 6)). FF4. The Examiner finds that McLaren discloses combinations of water, oil, and a benzimidazole that would be expected to have a density within the ranges recited in claims 9 and 10 (id. (citing McLaren at 5, l. 28– 6, l. 3)). FF5. McLaren discloses “improved methods of formulating compositions of anthelmintics (preferably benzimidazoles) for topical or transdermal administration” (McLaren 2:14–15). FF6. McLaren discloses that the method comprises the steps of (i) mixing at least one anthelmintic compound with a vehicle in which said compound(s) dissolves, suspends and/or emulsifies until the vehicle/active ingredient mixture is substantially homogeneous, (ii) before, simultaneously with, or after step (i), mixing a non-ionic emulsifier with an oil capable of solubilising the non- ionic emulsifier, said mixing being at a temperature where both the non-ionic emulsifier and oil are in a liquid phase, (iii) blending the mixtures of steps (i) and (ii) at a temperature at which all components are in the liquid phase so as to provide a substantially homogeneous mixture, (iv) lowering the temperature, or allowing the lowering of the temperature, of the mixture of step (iii) while mixing Appeal 2012-005078 Application 12/259,844 4 (preferably so that at least said non-ionic emulsifier is no longer in the liquid phase), and (v) mixing with the suspension of step (iv) a deflocculation agent/water (or other diluent) mixture to provide the anthelmintic micro suspension preparation. (Id. at 3:2-15.) FF7. McLaren discloses that [p]referably said composition comprises— Benzimidazole(s) 1% to 50% w/v, Transdermal vehicle(s) 2% to 80% w/v, Non-ionic emulsifier(s) 0.1% to 10%w/v, Oil(s) 0.10% to 10% w/v, Deflocculation agent(s) 0.1% to 10%, and Water or other suitable diluent 5% to 50% w/v. (Id. at 5:28-6:3.) FF8. McLaren discloses that, preferably, the benzimidazole is flubendazole, among others (id. at 6:4–7). FF9. McLaren discloses that, preferably, the “vehicle is selected from the group including isopropyl myristate, dimethyl sulphoxide, diacetone alcohol, n-methyl-2-pyrrolidone and 2 pyrrolidone” (id. at 6:8–9). FF10. McLaren discloses that Preferably said composition comprises— Oxfendazole 7.5% w/v Iso Propyl Myristate 66.0% w/v Sorbitan Stearate 1.0% w/v Sodium Lignosulphonate 0.9% w/v Canola Oil 0.5% w/v Deionised Water, up to the 100%. (Id. at 6:20-26.) Appeal 2012-005078 Application 12/259,844 5 FF11. McLaren discloses that “[p]referably said composition is about a 75mg/ml suspension of oxfendazole” (id. at 7:6). FF12. The Specification discloses that [t]o obtain the final formulation, in which the particles are coated with a suitable amount of the water immiscible liquid, the freshly prepared suspension is emulsified into a water phase . . . . In fact, the solid phase-water immiscible liquid phase is emulsified into the water phase, yielding a so called suspoemulsion (Spec. 6–7, ¶ 0027.) Analysis Appellants argue that McLaren does not anticipate claim 9 “because McLaren fails to disclose a ‘suspoemulsion’ containing a mixture of flubendazole and a water-immiscible liquid within the claimed density range” (App. Br. 5). Appellants argue that “McLaren only describes two- phase compositions, such as emulsions (i.e., liquid in a liquid) or suspensions (i.e., solid in a liquid) . . . [but] does not anticipate a suspoemulsion of at least three phases as required by the claims” (id.). The Examiner responds that the McClaren discloses preparations that “follow those of the instant [Specification]; benzimadazoles are mixed in a water immiscible liquid to provide homogeneous suspensions, adding emulsifier, blending and mixing into water” (Ans. 6 (citing McClaren at 6:20–26 and at 9 and 10)). The Examiner further responds that the “instant claims do not require a 3-phase system[] [and that] Appellants submitted a description of suspoemulsion but did not comment on it” (id.). Appellants reply that claim 9 “expressly claim[s] a ‘suspoemulsion’ comprising ‘a homogenous suspension in water of a mixture of . . . Appeal 2012-005078 Application 12/259,844 6 flubendazole and a water-immiscible liquid’” (Reply Br. 4 (emphasis removed)). Appellants further reply that the instant Specification discloses that the “suspoemulsion is formed when the solid phase-water immiscible liquid phase (i.e., the mixture of flubendazole and a water immiscible liquid) is emulsified into the water phase” (id. (citing the Spec. at 6:34–7:3 (emphasis removed))). Appellants argue that “a suspension of flubendazole and a water immiscible liquid is first formed and is subsequently combined with water via emulsification to form a ‘suspoemulsion’” (id.). Appellants argue that “the portions of McLaren pointed to by the Examiner describe the preparation of a suspension, not a suspoemulsion . . . [wherein] McClaren is completely devoid of any description of a suspoemulsion and the term ‘suspoemulsion’ is not present in McLaren” (id. at 5 (emphasis removed)). We agree with Appellants that the Examiner has not adequately explained how McClaren discloses the suspoemulsion of claim 9. “It is well settled that a claim is anticipated if each and every limitation is found either expressly or inherently in a single prior art reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). Contrary to the Examiner’s reasoning, the Specification makes clear that a suspoemulsion requires three phases, i.e. an emulsion formed by two liquid phases and a solid phase (FF 12). The Examiner has not pointed to anything in McClaren as disclosing a suspoemulsion. The fact that a suspoemulsion Appeal 2012-005078 Application 12/259,844 7 may result from certain general conditions disclosed in McClaren is not sufficient to establish anticipation. Thus, we reverse the rejection of independent claim 9 and dependent claim 10 as being anticipated by McClaren. SUMMARY We reverse the rejection of claims 9 and 10 under 35 U.S.C. § 102(b). REVERSED lp Copy with citationCopy as parenthetical citation