Ex Parte Dietrich et al

Patent Trial and Appeal BoardOct 22, 2012

12153585 (P.T.A.B. Oct. 22, 2012)

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. 12/153,585 05/21/2008 Rango Dietrich 27080UYY 7901 34375 7590 10/22/2012 NATH & ASSOCIATES PLLC 112 South West Street Alexandria, VA 22314 EXAMINER WAX, ROBERT A ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 10/22/2012 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 RANGO DIETRICH and HARTMUT NEY __________ Appeal 2010-012503 Application 12/153,585 Technology Center 1600 __________ Before FRANCISCO C. PRATS, STEPHEN WALSH, and ERICA A. FRANKLIN, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to oral dosage forms for administering compounds that treat diseases involving excess gastric acid secretion. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 11, 12 and 14-32 stand rejected and appealed (App. Br. 5). Claim 11, the only independent claim, is representative and reads as follows: Appeal 2010-012503 Application 12/153,585 2 11. An oral fixed combination administration form for an active compound, which is a pyridin-2-ylmethylsulfinyl-1H- benzimidazole or a pharmaceutically acceptable salt thereof, wherein said active compound is in a capsule in two different administration forms which have a different release of the active compound, wherein one administration form comprises the active compound together with a tablet disintegrant and bears a coating film for sustained-release, and an enteric coating film being absent, and wherein the other administration form comprises the active compound and which bears an enteric coating film. The following rejections are before us for review: (1) Claims 11, 12, and 14-32, under 35 U.S.C. § 103(a) as obvious over Dietrich 1 (Ans. 5-8); and (2) Claims 11, 12, and 14-32, under 35 U.S.C. § 103(a) as obvious over Chen 2 and Dietrich (Ans. 11-15). OBVIOUSNESS – DIETRICH In rejecting the pending claims as obvious over Dietrich alone, the Examiner summarized Dietrich as teaching “an oral pantoprazole fixed combination composition in suitable forms, such as tablets, coated tablets, pellets and microtablets in capsules. The composition provides delayed and controlled release of the active ingredient. Dietrich et al. teach tablet disintegrants, film-forming polymers, enteric coatings and various additives” (Ans. 7). Based on these teachings, the Examiner concluded that an ordinary artisan would have considered it prima facie obvious “to use the specific teachings of Dietrich et al. who teach a varied release pantoprazole 1 WO 97/02020 A1 (published January 23, 1997). 2 U.S. Patent No. 5,260,069 (issued Nov. 9, 1993). Appeal 2010-012503 Application 12/153,585 3 formulation comprising disintegrants, film-forming polymers, enteric coatings, additives and the like to provide a beneficial drug formulation. The expected result would be an effective formulation in the treatment of various disorders of the stomach” (id. at 7-8). As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Ultimately, “[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Here, we agree with Appellants that a preponderance of the evidence does not support the Examiner‟s finding that Dietrich would have suggested the claimed dosage form. Specifically, claim 11, the only independent, recites a capsule that contains the benzimidazole active agent in two different administration forms which provide different release of the agent. One of the administration forms includes the active compound with an enteric coating film. The other form includes the active agent, a disintegrant, and a sustained release coating. Claim 11 specifies, however, that the disintegrant- requiring form may not have an enteric coating. Appeal 2010-012503 Application 12/153,585 4 We acknowledge that Dietrich describes dosage forms that contain the active agent in an extended release portion and a rapid release portion: Rapid release of part of the pantoprazole and extending release of another part can be achieved, for example, also by layered tablets or multilayer tablets, in which case part of the pantoprazole is present in an outer coating in a form without retarding its release; this is followed by another coating containing the antimicrobially-active ingredient and then the core with the pantoprazole, whose release is extended in a suitable manner. (Dietrich 5.) However, while the Examiner reasoned that an ordinary artisan would have modified Dietrich‟s expressly described dosage forms to instead prepare the capsule of claim 11 “to provide a beneficial drug formulation” (Ans. 8), the Examiner points to no evidence of record clearly or specifically suggesting that the claimed combination of elements would have been viewed as equivalent to, or useful or suitable as, the therapeutic composition of Dietrich. Conclusory statements that lack a rational underpinning or evidentiary support are inadequate to support a conclusion of obviousness. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”); see also In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000) (“Whether the Board relies on an express or an implicit showing, it must provide particular findings related thereto. Broad conclusory statements standing alone are not „evidence.‟” (Citation omitted)). Appeal 2010-012503 Application 12/153,585 5 Moreover, as Appellants argue, Dietrich teaches that an enteric coating should be used to protect the pantoprazole in its formulations from the acidity in the stomach, due to the compound‟s acid-lability: Because of a great tendency to decompose in a neutral and, in particular, acidic environment, which also results in highly colored decomposition products, for oral compositions, it is necessary on the one hand to keep pantoprazole in an alkaline environment and, on the other hand, to protect it from exposure to acids. It is generally known to coat tablets or pellets which contain an acid-labile active ingredient with an enteric coating which, after passage through the stomach, rapidly dissolves in the alkaline medium in the intestine. In the case of pantoprazole, which i[s] very acid-labile, it is necessary to process it in the tablet core or in pellets in the form of its alkaline salts, for example as sodium salts, or together with alkaline substances. (Dietrich 6; see also id. at 9-14 (working examples of Dietrich consistently use an enteric outer coating).) Thus, reading the reference as a whole, we agree with Appellants that Dietrich would not have prompted an ordinary artisan to prepare a pantoprazole dosage form without an enteric coating, as claim 11 expressly requires. Rather, as Appellants argue, an ordinary artisan would have protected the acid-labile pantoprazole from degradation in the acidic environment of the stomach by providing an enteric coating. In sum, we are not persuaded, for the reasons discussed, that a preponderance of the evidence supports the Examiner‟s prima facie case that claim 11 would have been obvious to an ordinary artisan in view of Dietrich. We therefore reverse the Examiner‟s obviousness rejection of that claim, and its dependents, over Dietrich. Appeal 2010-012503 Application 12/153,585 6 OBVIOUSNESS – CHEN AND DIETRICH In rejecting claims 11, 12, and 14-32 as obvious over Chen and Dietrich, the Examiner cited Chen as disclosing a drug dosage form in which “a plurality of populations of pellets is provided within a unit dosage form such as a capsule or tablet” (Ans. 11). The Examiner noted that, due to the use of coatings containing different ingredients, Chen‟s “dosage units are readily adaptable to a variety of timing intervals” (id.). The Examiner further noted that Chen described using enteric coatings with its dosage forms, and also noted Chen‟s teaching that its dosage forms could be used to deliver a number of different categories of drugs (id. at 12). The Examiner conceded, however, that Chen did not teach delivering the claimed benzimidazoles in its dosage forms (id.). Nonetheless, the Examiner concluded that “[i]t is deemed obvious to one of ordinary skill in the art to employ any particular active ingredient, based on the intended or desired purpose” (id.). The Examiner also reasoned that, in view of Dietrich‟s teaching of delivering pantoprazole with a varying release rate, an ordinary artisan would have considered it obvious “to use the combined teachings of Dietrich et al. with[] Chen to obtain suitable formulations of a benzimidazole, particularly pantoprazole for treating gastric acid conditions. The expected result would be a highly effective pantoprazole composition, which is beneficial for treating disorders of the stomach, as similarly desired by Applicants” (id. at 13). While this rejection arguably presents a close case, we again agree with Appellants that a preponderance of the evidence does not support the Examiner‟s conclusion of prima facie obviousness. Appeal 2010-012503 Application 12/153,585 7 We acknowledge that, unlike Dietrich, Chen teaches a dosage form that includes distinct populations of drug-containing pellets having different release characteristics (see Chen, abstract). We also acknowledge Chen‟s disclosure of two strategies for controlling release rate, one of which includes the use of an enteric coating (see id. at col. 2, ll. 13-31), as well as a “second means for altering release of the drug compris[ing] the incorporation into the coating of material which reduces the permeability of the coating” (id. at col. 2, ll. 33-35). Thus, in one embodiment Chen describes an aggregate of five distinct types of pellets having a spectrum of release characteristics allowing extended release of a drug over time (see id. at col. 5, ll. 32-65). Accordingly, it might be true that Chen suggests formulations that include a plurality of pellets, some of which have an enteric coating and some of which do not, and that a variety of drugs can be delivered using that approach. Nonetheless, as noted above, Dietrich consistently teaches that when preparing therapeutic pantoprazole compositions, the dosage form should include an enteric coating (see Dietrich 6; also, id. at 9-14 (working examples of Dietrich all use an enteric outer coating)). We are not persuaded that an ordinary artisan would have been prompted by Chen‟s generic disclosure of suitable drug dosage forms to diverge from Dietrich‟s specific teaching that the drug used in its formulations requires protection by an enteric coating due to its acid lability. We are, therefore, also unpersuaded that an ordinary artisan would have considered it obvious, even in light of Chen‟s teachings, to prepare Dietrich‟s pantoprazole in a dosage form lacking an enteric coating, as required by Appellants‟ claim 11. Appeal 2010-012503 Application 12/153,585 8 As we are not convinced, for the reasons discussed, that a preponderance of the evidence supports the Examiner‟s conclusion that Chen and Dietrich would have rendered claim 11 prima facie obvious to an ordinary artisan, we reverse the Examiner‟s rejection of that claim, and its dependents, over those references. SUMMARY We reverse the Examiner‟s obviousness rejection of claims 11, 12, and 14-32 over Dietrich. We also reverse the Examiner‟s obviousness rejection of claims 11, 12, and 14-32 over Chen and Dietrich. REVERSED cdc