Ex Parte Brzeczko et alDownload PDFPatent Trial and Appeal BoardJan 13, 201512019666 (P.T.A.B. Jan. 13, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ALBERT W. BRZECZKO and JOHN A. DONEY __________ Appeal 2012-007345 Application 12/019,666 Technology Center 1600 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ROBERT A. POLLOCK, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an oxcarbazepine composition. The Examiner rejected the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as ISP Investments Inc. (see App. Br. 3). Appeal 2012-007345 Application 12/019,666 2 Statement of the Case Background “Oxcarbazepine is . . . an anticonvulsant and is currently marketed by Novartis Pharmaceuticals under the branded name TRILEPTAL®” (Spec. 2 ¶ 2). The Claims Claims 1–9 are on appeal. Independent claim 1 is representative and reads as follows: 1. A composition comprising a solid solution wherein the solid solution comprises oxcarbazepine and one or more solubility-enhancing polymer(s) wherein said oxcarbazepine is substantially amorphous and exhibits enhanced bioavailability compared to a control composition without the solubility-enhancing polymer. The issue The Examiner rejected claims 1–9 under 35 U.S.C. § 102(e) as anticipated by Blau2 (Ans. 5–7). The Examiner finds that “Blau teaches a pharmaceutical composition comprising, a) spray granulated oxcarbazepine, and b) at least one pharmaceutical excipient” (Ans. 5). The Examiner finds that “Blau teaches spray-granulated oxcarbazepine is a product of spraying a dispersion of oxcarbazepine particles on air–fluidized excipient particles” (Ans. 6). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Blau anticipates the claims? 2 Blau, S., US 2007/0178164 A1, published Aug. 2, 2007. Appeal 2012-007345 Application 12/019,666 3 Findings of Fact 1. Blau teaches “a pharmaceutical composition comprising oxcarbazepine and at least one pharmaceutical excipient, wherein the oxcarbazepine in the composition has a broad particle size distribution and an enhanced oxcarbazepine dissolution rate” (Blau, abstract). 2. The Specification teaches that the [T]erm “solid solution” as used herein refers to a type of solid dispersion wherein one component is molecularly dispersed throughout another component such that the system is chemically and physically uniform and homogeneous throughout. These systems do not contain any significant amounts of active ingredients in their crystalline or microcrystalline state as evidenced by thermal analysis or x-ray diffraction (Spec. 6–7 ¶ 22). 3. The Specification teaches that the “invention includes other methods described herein that are also useful in converting oxcarbazepine to the amorphous state and corresponding enhanced bioavailability. Those methods include, without limitation . . . granulation” (Spec. 7 ¶ 24). 4. Blau teaches “the production of the pharmaceutical composition comprising a broad particle size distribution of oxcarbazepine comprises spray granulation of at least one population of oxcarbazepine particles, either from small drug particles or from large drug particles” (Blau 6 ¶ 89). 5. The Specification teaches that “[s]olubility-enhancing polymers that are suitable for use in the mixtures of the present invention should result in conversion of at least some of the crystalline oxcarbazepine to the amorphous state . . . examples of useful polymers include, but are not limited Appeal 2012-007345 Application 12/019,666 4 to . . . hydroxypropylmethyl cellulose . . . [and] polyvinylpyrrolidone” (Spec. 12 ¶ 36). 6. Blau teaches that the “oxcarbazepine is milled in a liquid dispersion by a homogenizer. . . . Preferably, such reduction of the particle size of oxcarbazepine by wet milling is carried out in the presence of a hydrophilic polymer or stabilizer. A preferred hydrophilic polymer or stabilizer is a hypromellose (Hydroxypropylmethylcellulose, HPMC)” (Blau 5 ¶ 86). 7. Blau teaches that the “oxcarbazepine pharmaceutical compositions comprising a broad particle size distribution as in the present invention further may contain excipients such as . . . hydroxypropyl methyl cellulose and Povidone [i.e. polyvinylpyrrolidone]” (Blau 5 ¶ 76). 8. Blau teaches that “[s]olid pharmaceutical compositions that are compacted into a dosage form, such as a tablet, may include excipients whose functions include helping to bind the active ingredient and other excipients together after compression. Binders for solid pharmaceutical compositions include . . . hydroxypropyl methyl cellulose . . . povidone” (Blau 5 ¶ 79). 9. Blau teaches that “[o]xcarbazepine raw material . . . was dispersed in a solution of 240 g hypromellose (Pharmacoat 603) in 4800 g of purified water. The Pharmacoat was added to the water and mixed until a clear mixture was obtained” (Blau 7 ¶ 104). Blau then teaches performance of a series of granulation and spraying steps, concluding with a step where the oxcarbazepine and hypromellose “mixture was subsequently pressed into tablets” (Blau 8 ¶ 110). Appeal 2012-007345 Application 12/019,666 5 Principles of Law “A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 5–15; FF 1–8) and agree that claim 1 is anticipated by Blau. We address Appellants’ arguments below. Appellants contend that “Blau fails to disclose or suggest a composition containing the active and a solubility-enhancing polymer in the form of a solid solution as set forth in claim 1. Furthermore, Blau fails to disclose compositions wherein the oxcarbazepine is substantially amorphous” (App. Br. 9). Appellants contend that “[s]praying oxcarbazepine from a polymer solution (as in Blau example 1) would result in polymer coated active particles but not solid solutions” (App. Br. 10). Appellants contend that “the homogenous granulate of Blau is not a solid Appeal 2012-007345 Application 12/019,666 6 solution since one component is not molecularly dispersed throughout another component” (App. Br. 10). We are not persuaded. The Specification defines a “solid solution” as “a type of solid dispersion wherein one component is molecularly dispersed throughout another component such that the system is chemically and physically uniform and homogeneous” (Spec. 6–7 ¶ 22; FF 2). Blau teaches that “[o]xcarbazepine raw material . . . was dispersed in a solution of 240 g hypromellose (Pharmacoat 603) in 4800 g of purified water. The Pharmacoat was added to the water and mixed until a clear mixture was obtained” (Blau 7 ¶ 104; FF 9). Blau then teaches performance of a series of granulation and spraying steps, concluding with a step where the oxcarbazepine and hypromellose “mixture was subsequently pressed into tablets” (Blau 8 ¶ 110; FF 9). We agree with the Examiner that when Blau forms a clear mixture of the oxcarbazepine and hypromellose (FF 9), the evidence supports the Examiner’s position that oxcarbazepine “would be molecularly dispersed [throughout] the hypromellose (HPMC) to provide a system that is chemically and physically uniform and homogeneous throughout” (Ans. 10). After Blau’s mixture is homogenized, sprayed, granulated and pressed into tablets, the Examiner reasonably finds that the resultant solid tablet inherently satisfies the requirement for a “solid solution” of oxcarbzepine and the solubility enhancer hypromellose (FF 5, 6). Best, 562 F.2d at 1255. While Appellants repeatedly argue that the process of Blau would not result in a “solid solution,” Appellants have provided no evidence supporting Appeal 2012-007345 Application 12/019,666 7 this argument. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Appellants contend that the “significant differences between the sprayed dispersion in Blau and the solid solution set forth in claim 1 of the pending application clearly indicate that it is improper to assume that this property would be inherent” (App. Br. 11). We are not persuaded. We find that the instant facts are precisely the type of situation envisioned by Best where an Examiner should properly apply an inherency argument. Blau teaches a composition comprising the same drug, oxcarbazepine, as required by claim 1 (FF 1), combined with a solubility enhancer, hydroxypropylmethyl cellulose (FF 6) identified in Appellants’ Specification (FF 5) and required by Appellants’ claim 3. Blau further teaches producing the composition by dissolving the components together (FF 9) and granulation of the particles (FF 4), and Appellants’ Specification teaches that methods “useful in converting oxcarbazepine to the amorphous state and corresponding enhanced bioavailability . . . include, without limitation . . . granulation” (Spec. 7 ¶ 24; FF 3). Thus, Blau teaches a product composed of identical components made using a process identified by Appellants’ Specification as achieving an amorphous state and enhanced bioavailability (FF 1–9). Appellants provide no evidence in rebuttal. Conclusion of Law The evidence of record supports the Examiner’s conclusion that Blau anticipates the claims. Appeal 2012-007345 Application 12/019,666 8 SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as anticipated by Blau. Pursuant to 37 C.F.R. § 41.37(c), claims 2– 9 fall with claim 1, as these claims were not argued separately. 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 cdc Copy with citationCopy as parenthetical citation