Ex Parte Ray et al

Patent Trial and Appeal BoardOct 31, 2012

11814501 (P.T.A.B. Oct. 31, 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. 11/814,501 07/23/2007 Roderick Jack Ray 0003.0520/PC32125A 5729 152 7590 10/31/2012 CHERNOFF, VILHAUER, MCCLUNG & STENZEL, LLP 601 SW Second Avenue Suite 1600 PORTLAND, OR 97204-3157 EXAMINER WHEELER, THURMAN MICHAEL ART UNIT PAPER NUMBER 1619 MAIL DATE DELIVERY MODE 10/31/2012 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 RODERICK JACK RAY, DWAYNE THOMAS FRIESEN, MARSHALL DAVID CREW, RICHARD FRANK FALK, and SANJAY KONAGURTHU __________ Appeal 2011-012533 Application 11/814,501 Technology Center 1600 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a fast- disintegrating dosage form. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1-3 and 5-9 are on appeal. Independent claim 1 is representative and reads as follows: Appeal 2011-012533 Application 11/814,501 2 1. A fast-disintegrating dosage form comprising a drug and a microporous binder, said microporous binder being free from said drug and comprising a plurality of particles, each of said particles comprising an aqueous-soluble ionizable cellulosic polymer selected from hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, carboxymethyl ethyl cellulose, cellulose acetate phthalate, cellulose acetate trimellitate, and mixtures thereof, and a wicking agent, said wicking agent being selected from the group consisting of polyols, salts, organics, low molecular-weight polymers, and mixtures thereof, wherein said aqueous- soluble polymer and said wicking agent together comprise at least about 60 wt% of said microporous binder, and wherein said microporous binder has a porosity of at least about 70%. The Examiner rejected claims 1-3 and 5-9 under 35 U.S.C. § 103(a) as unpatentable over Fu, 1 Allen, 2 and Chidlaw. 3 Claims 2-3 and 5-9 have not been argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Examiner found that Fu taught a fast-disintegrating tablet comprising a drug, a porous and plastic material, a water penetration enhancer (wicking agent) and a binder. (Ans. 5.) The Examiner also found that Fu taught that its highly plastic granules can be prepared by first combining the porous/ plastic material, the wicking agent, and the binder, without drug, and then mixing the drug in later. (Id.) Additionally, the 1 Patent Application Publication No. WO 2004/100857 A2 by Yourong Fu et al., published Nov. 25, 2004. 2 US Patent No. 5,776,491 issued to Loyd V. Allen, Jr. et al., Jul. 7, 1998. 3 Patent Application Publication No. US 2004/0121015 A1 by Mark B. Chidlaw et al., published Jun. 24, 2004. Appeal 2011-012533 Application 11/814,501 3 Examiner found that Fu disclosed binder materials that are aqueous-soluble non-ionizable cellulosic polymers, e.g., cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose (HPMC). (Id.) However, the Examiner found that Fu did not explicitly embody an aqueous- soluble ionizable cellulosic polymer. (Id. at 6.) The Examiner found that Chidlaw taught a controlled release pharmaceutical delivery composition comprising an immediate release core comprising a solid, amorphous dispersion of a drug and an inert and aqueous-soluble ionizable polymer, such as hydroxypropyl methylcellulose acetate succinate (HPMCAS). (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made that inert and water soluble ionizable polymer such as HPMCAS would be a preferred binder to use in a fast-melting pharmaceutical tablet in place of the non- ionizable HPMC disclosed by Fu, since Chidlaw also taught the use of HPMC as a polymer, but explicitly taught that HPMCAS was preferred for providing an immediate release dosage form. (Id.) Appellants contend that Chidlaw taught “that HPMCAS is the preferred material for forming a solid amorphous dispersion- not for making an immediate release dosage form.” (App. Br. 3.) Appellants assert that “while the Chidlaw core itself can be an immediate release composition, that core is taught to be coated with a rate-limiting coating so that the composition provides controlled release as opposed to immediate release of the drug.” (Id.) Additionally, Appellants assert that there is no motivation to combine Chidlaw with Fu and Allen because Chidlaw is directed to a controlled-release composition, while the compositions of Fu and Allen are both rapidly released. (Id.) Appeal 2011-012533 Application 11/814,501 4 Further, Appellants assert that Chidlaw taught “HPMCAS to be useful for only two things: (1) for making a solid amorphous dispersion of the drug where the drug is dispersed in the polymer [0077]; and (2) as a pore-former in a coating for a dosage form such as a tablet [0117]).” (Id. at 4.) Therefore, according to Appellants, the combination of Chidlaw and Fu would not yield the claimed invention “since (1) the binder (e.g. HPMCAS) is recited to be „free from said drug,‟ and (2) there is no claim to a coated dosage form having, e.g., HPMCAS therein in any form, let alone as a pore- former.” (Id.) After considering all the evidence and arguments, we conclude that the record supports a conclusion of prima facie obviousness. We are not persuaded of nonobviousness by Appellants‟ assertion that Chidlaw taught “that HPMCAS is the preferred material for forming a solid amorphous dispersion- not for making an immediate release dosage form.” (App. Br. 3.) As Appellants acknowledge that “the Chidlaw core itself can be an immediate release composition, [and] that core is taught to be coated with a rate-limiting coating so that the composition provides controlled release as opposed to immediate release of the drug.” (Id.) However, there is no teaching in Chidlaw limiting its preparation or use of the drug dispersed in a polymer, such as HPMCAS, to a particular dosage form. Rather, Chidlaw generally taught that a solid, amorphous dispersion may be prepared by combining the drug and a suitable dispersion polymer, which included ionizable and non-ionizable cellulosic polymers, of which HPMCAS was among those particularly preferred. (Chidlaw [0077]; Ans. 6-7.) Therefore, we find that a skilled artisan would have found ionizable and non-ionizable cellulosic polymers to be equivalent in view of Chidlaw‟s disclosure and we Appeal 2011-012533 Application 11/814,501 5 agree with the Examiner that the artisan would have been motivated to substitute Fu‟s HPMC with HPMCAS since both polymers were disclosed as suitable polymers by Chidlaw, and wherein HPMCAS was among the particular preferred polymers. The Examiner‟s combination amounted to no more than the simple substitution of one known element for another. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416-17 (2007). Additionally, while we agree with Appellants that Chidlaw disclosed HPMCAS for making a solid amorphous dispersion of the drug where the drug is dispersed in a polymer, we do not agree with Appellants‟ assertion that such use would not yield the claimed invention which requires the binder being “free from said drug.” (See App. Br. 4.) The Specification defines the term “free from the drug” as meaning “that the microporous binder, prior to incorporation into a dosage form, contains less than about 10 wt% drug.” (Spec. 3, ll. 7-8.) Chidlaw‟s teaching of suitable dispersion polymers for use in preparing a solid, amorphous dispersion of the drug does not teach or suggest that the polymer contains any drug prior to incorporation into the dosage form. Thus, we find that Chidlaw‟s polymers are “free from said drug,” as required by the claimed invention. Moreover, even if Chidlaw‟s preparation of the drug in a dispersion with a polymer is considered to be a step taken “prior to incorporation into a dosage form,” Chidlaw expressly taught that the dispersion may contain about 5% to 90 wt% drug, and preferably 10 to 70 wt%. (Chidlaw [0077]). Thus, Chidlaw taught dispersions comprising less than about 10 wt% of drug, which also satisfies the Specification definition of “free from the drug.” Appeal 2011-012533 Application 11/814,501 6 SUMMARY We affirm the obviousness rejection. 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 alw