BioDelivery Sciences International, Inc.v.MonoSol Rx, LLCDownload PDFPatent Trial and Appeal BoardNov 5, 201413853237 (P.T.A.B. Nov. 5, 2014) Copy Citation Trials@uspto.gov Paper No. 7 Tel: 571.272.7822 Entered: November 5, 2014 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ BIODELIVERY SCIENCES INTERNATIONAL, INC., Petitioner, v. MONOSOL RX, LLC, Patent Owner. _______________ Case IPR2014-00794 Patent 8,652,378 B1 _______________ Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and ZHENYU YANG, Administrative Patent Judges. YANG, Administrative Patent Judge. DECISION Denying Institution of Inter Partes Review 37 C.F.R. § 42.108 IPR2014-00794 Patent 8,652,378 B1 2 I. INTRODUCTION BioDelivery Sciences International, Inc. (“Petitioner”) filed a Petition to institute an inter partes review of claims 1–29 of U.S. Patent No. 8,652,378 B1 (“the ’378 patent”). Paper 2 (“Pet.”). MonoSol Rx, LLC (“Patent Owner”) timely filed a Preliminary Response. Paper 6 (“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314. For the reasons provided below, we determine Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Because the Petition fails to meet the threshold requirement set forth in 35 U.S.C. § 314(a), we deny the Petition. A. Related Matters The ’378 patent is terminally disclaimed over U.S. Patent No. 7,897,080 (“the ’080 patent”), which is terminally disclaimed over U.S. Patent Nos. 7,357,891 (“the ’891 patent”), 7,425,292 (“the ’292 patent”), 7,666,337 (“the ’337 patent”), and 8,685,437 (“the ’437 patent”). The ’437 patent is terminally disclaimed over, in addition to the ’891, ’292, and ’337 patents, U.S. Patent No. 7,824,588 (“the ’588 patent”). Pet. 1–3; Paper 5, 3. Each of the ’891, ’292, ’337, ’080, and ’588 patents was reexamined (control numbers 90/012,098, 90/012,097, 95/002,171, 95/002,170, and 95/001,753, respectively). Pet. 1–3; Paper 5, 3. The reexamination certificates for the ’891 and ’292 patents have been issued, with all original claims cancelled or amended. Pet. 2; Paper 5, 3. All claims of the ’588 patent were finally rejected and the Board affirmed the rejections. Ex. 1017. All claims of the ’080 and ’337 patents were also finally rejected. Pet. 2–3. IPR2014-00794 Patent 8,652,378 B1 3 Patent Owner has appealed the rejections and the appeals are pending before the Board. B. The ’378 Patent The ’378 patent discloses methods for making rapid dissolve thin film drug delivery compositions for the oral administration of active components. Ex. 1001, Abstract. The compositions may be formed by wet casting methods, where the film is cast and controllably dried. Id. at Abstract, 6:53– 64. According to the Specification, the active components are provided as particles uniformly distributed throughout the film composition. Id. at Abstract. C. Illustrative Claims Claims 1 and 27 are independent claims. Claims 2–26 depend from claim 1, and claims 28 and 29 depend from claim 27. Claim 1 reads: 1. A process for manufacturing a resulting pharmaceutical film suitable for commercialization and regulatory approval said resulting pharmaceutical film having a substantially uniform distribution of a desired amount of a pharmaceutical active in individual doses of the resulting pharmaceutical film, comprising the steps of: (a) forming a visco-elastic polymer matrix by mixing, said matrix comprising a polymer selected from the group consisting of water-soluble polymers, water-swellable polymers and combinations thereof, a solvent selected from the group consisting of water, a polar organic solvent and combinations thereof, and pharmaceutical active, which polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105 sec-1, said polymer matrix having a substantially uniform distribution of said pharmaceutical active; (b) casting said polymer matrix; (c) conveying said polymer matrix through a drying apparatus and drying said polymer matrix, to rapidly IPR2014-00794 Patent 8,652,378 B1 4 remove at least a portion of said solvent from said matrix to form a visco-elastic film having said pharmaceutical active substantially uniformly distributed throughout by rapidly increasing the viscosity of said polymer matrix upon initiation of drying within about the first 4 minutes to maintain said uniform distribution of said pharmaceutical active by locking-in or substantially preventing migration of said pharmaceutical active, wherein the temperature of the polymer matrix is 100° C. or less, wherein content uniformity of said active in substantially equal sized individual dosage units of said visco-elastic film is such that the amount of the active varies by no more than 10% from the desired amount; and (d) forming the resulting pharmaceutical film having a water content of 10% or less and a thickness of about 0.1 mils to about 10 mils from said visco-elastic film, wherein said resulting pharmaceutical film having said substantially uniform distribution of pharmaceutical active by said locking-in or substantially preventing migration of said pharmaceutical active is maintained, such that content uniformity of said active in substantially equal sized individual dosage units of said resulting pharmaceutical film is such that the amount of the active varies by no more than 10% from the desired amount. Claim 27 additionally requires, in step (c): wherein any top air flow does not overcome the inherent viscosity of the visco-elastic film and any top air flow is insufficient to cause one or more of the following: (i) surface skinning prior to drying the depth of the film; (ii) surface rippling; (iii) self-aggregation of components; (iv) non- uniformity in thickness of the film; and (v) non-uniformity of mass per unit volume . . . . Claim 27 further differs from claim 1 in that step (d) of claim 27 does not recite the resulting pharmaceutical film “having a water content of 10% or less and a thickness of about 0.1 mils to about 10 mils.” IPR2014-00794 Patent 8,652,378 B1 5 D. The Asserted Grounds of Unpatentability Petitioner asserts that claims 1–13, 15, and 23–29 are unpatentable under 35 U.S.C. § 102(b) over Chen.1 Petitioner also contends that claims 1–29 are unpatentable under 35 U.S.C. § 103(a) over Chen alone, over the combination of Chen and Staab,2 or over the combination of Chen and Strobush.3 II. DISCUSSION A. Claim Construction In an inter partes review, the Board interprets a claim term in an unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b). Under that standard, we assign claim terms their ordinary and customary meaning, as understood by a person of ordinary skill in the art, in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). All claims either recite, or through their dependency require, the limitation of “polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105 sec-1.” Patent Owner asks us to construe this term. Prelim. Resp. 6–10. Although 1 Chen et al., Int’l Pub. No. WO 00/42992, published on July 27, 2000 (Ex. 1003) (“Chen”). 2 Staab, U.S. Patent No. 5,393,528, issued on Feb. 28, 1995 (Ex. 1004) (“Staab”). 3 Strobush et al., U.S. Patent No. 5,881,476, issued on Mar. 16, 1999 (Ex. 1005) (“Strobush”). IPR2014-00794 Patent 8,652,378 B1 6 Petitioner does not propose any construction, the declarations of Drs. Cohen and Reitman, Petitioner’s witnesses, provide some relevant discussion. See Declaration by Edward D. Cohen, Ph.D. (Ex. 1007), ¶¶ 29, 30, 44; Declaration by Maureen Reitman Sc.D. (Ex. 1006), Figure 1, Table 1. According to Patent Owner, the plain and ordinary meaning of the phrase “shear-thinning pseudoplastic fluid” is a “non-Newtonian fluid that has a viscosity that decreases with an increasing shear rate.” Prelim. Resp. 7. Dr. Cohen states that “[a]ll polymers are shear thinning, even when they appear to be Newtonian in the usual viscometers.” Ex. 1007 ¶ 30. Dr. Cohen, however, agrees that the shear-thinning or pseudoplastic behavior “means that the viscosity decreases with increasing shear rate.” Id. ¶ 29. We are satisfied that the Specification of the ’378 patent supports construing a “shear-thinning pseudoplastic fluid” as a “fluid having a viscosity that decreases with an increasing shear rate.” See Ex. 1001, 24:54– 56. This determination as to the scope of this term is sufficient for purposes of this Decision, and we need not address further whether such a fluid must be non-Newtonian. In step (a), independent claims 1 and 27 require the polymer matrix to exhibit shear-thinning pseudoplastic behavior “when exposed to shear rates of 10-105 sec-1.” Patent Owner emphasizes that the use of the plural term “rates” dictates that the polymer matrix must be a shear-thinning pseudoplastic fluid during film casting over multiple potential shear rates. Prelim. Resp. 7. Patent Owner also contends that the claim language mandates that “the polymer matrix must be a shear-thinning pseudoplastic fluid when exposed to shear rates throughout the entire range of 10-105 sec-1,” and not just a portion of the range. Id. We agree. IPR2014-00794 Patent 8,652,378 B1 7 First, the claim language “shear rates,” in the plural form, limits the polymer matrix, as recited in step (a) of claims 1 and 27, to one that must exhibit the shear-thinning property when exposed to multiple shear rates. Petitioner does not explicitly discuss the significance of the plural form of the phrase “shear rates.” We observe, however, that in support of the Petition, Dr. Reitman tested the viscosity of allegedly reproduced prior-art polymer matrix at multiple shear rates. See Ex. 1006, Figure 1, Table 1. Second, regarding the limitation “exposed to shear rates of 10-105 sec-1,” Petitioner does not address whether this language requires exposure to the entire range. Instead, citing Dr. Cohen’s declaration, Petitioner asserts that “the recited range of shear rates is so broad as to encompass any shear rate that might be encountered in the coating field.” Pet. 20 (citing Ex. 1007 ¶ 44). Assuming this statement is correct, the broad range of shear rates is not, as Dr. Cohen declares, “meaningless.” See Ex. 1007 ¶ 44. To the contrary, requiring the polymer matrix to exhibit shear-thinning pseudoplasticity when exposed to the entire range of shear rates imposes a stringent limitation. This conclusion is supported by the ’378 patent: The rheology requirements for the inventive compositions and films are quite severe. This is due to the need to produce a stable suspension of particles, for example 30-60 wt %, in a viscoelastic fluid matrix with acceptable viscosity values throughout a broad shear rate range. During mixing, pumping, and film casting, shear rates in the range of 10-105 sec.-1 may be experienced and pseudoplasticity is the preferred embodiment. Ex. 1001, 24:60–67 (emphases added). When read in view of the Specification, the claims require that the polymer matrix during film casting must be a shear-thinning pseudoplastic fluid when exposed to shear rates throughout the entire range of 10–105 sec-1. IPR2014-00794 Patent 8,652,378 B1 8 The parties also dispute the construction of the following terms: “substantially uniform distribution,” “film suitable for commercialization and regulatory approval,” and “forming the resulting . . . film.” Pet. 9–17; Prelim. Resp. 10–28. Because the construction of the shear-rates-related term discussed above is dispositive, we decline to construe these three terms for purposes of this Decision. B. Patentability Analysis 1. Anticipation Petitioner asserts that Chen anticipates claims 1–13, 15, and 23–29 of the ’378 patent. Pet. 19–37. Specifically, Petitioner refers to Chen for disclosing forming a polymer matrix by mixing a polymer, a solvent, and a pharmaceutical active, as recited in step (a) of independent claims 1 and 27. Id. at 19 (citing Ex. 1003, 15:19–26). Petitioner, however, does not point to any disclosure in Chen for disclosing “polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105 sec-1,” also recited in step (a). Instead, Petitioner attempts to establish the unpatentability of these claims through the inherency doctrine. In support, Petitioner relies on the declaration of Dr. Reitman, who states that she reproduced the pharmaceutical films according to Example 7 in Chen, and then tested them. See Ex. 1006 ¶¶ 5–13. According to Petitioner, “Dr. Reitman observed that a polymer matrix formed according to Chen’s Example 7 was a shear-thinning pseudoplastic fluid when exposed to shear rates of 10 to 103 sec-1.” Id. at 20–21 (citing Ex. 1006 ¶ 13). Patent Owner counters that Petitioner fails to show inherent anticipation by Chen. Prelim. Resp. 34–44. Among other challenges, Patent Owner criticizes Dr. Reitman’s “re-creation” of Example 7 and questions the IPR2014-00794 Patent 8,652,378 B1 9 reasoning and methodology underlying Dr. Reitman’s testimony. Id. at 36– 44. We need not address the majority of these disputes because we determine that the information presented in the Petition fails to establish a reasonable likelihood that the polymer matrix formed according to Chen’s Example 7 is a shear-thinning pseudoplastic fluid when exposed to shear rates above 103 sec-1, specifically, in the range of 103–105 sec-1. See id. at 43. As explained above in the claim construction section, the claim language, read in view of the Specification, dictates that the polymer matrix during film casting must be a shear-thinning pseudoplastic fluid throughout the entire shear rate range of 10–105 sec-1. See supra Section II.A. Dr. Reitman testifies that “[t]he viscosity as a function of shear rate was recorded from 10 to 103 sec-1” (Ex. 1006 ¶ 12); and Petitioner accurately presents the results that the polymer matrix formed according to Example 7 is “a shear-thinning pseudoplastic fluid when exposed to shear rates of 10 to 103 sec-1” (Pet. 20–21). Nowhere in the Petition, however, does Petitioner address whether the same polymer matrix exhibits the shear-thinning pseudoplastic property when exposed to shear rates above 103 sec-1 and up to 105 sec-1. We observe that Dr. Cohen testifies that “[t]he person of ordinary skill in the art would have expected that this behavior would to [sic] continue at shear rates above 103 sec-1.” Ex. 1007 ¶ 75. Petitioner, however, does not make this argument or refer to this statement in the Petition. As a result, pursuant to our Rules, we decline to consider this information. See 37 C.F.R. § 42.22(a)(2); 37 C.F.R. § 42.6(a)(3). Further, even if we did consider it, this statement would fail to support Petitioner’s inherent IPR2014-00794 Patent 8,652,378 B1 10 anticipation argument for two reasons. First, because Dr. Cohen does not cite to credible evidence or provide persuasive explanation to support this opinion, we would accord it little weight. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”). Second, anticipation by inherency requires that “the missing descriptive matter is necessarily present in the thing described in the reference.” Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991). Dr. Cohen’s unexplained, conclusory testimony that a skilled artisan “would have expected” a certain result constitutes probabilities or possibilities, which is insufficient to establish inherency. See id. at 1269. In sum, Petitioner has failed to establish a reasonable likelihood that the polymer matrix formed according to Example 7 in Chen is a shear- thinning pseudoplastic fluid “when exposed to shear rates of 10-105 sec-1.” As a result, Petitioner has failed to establish a reasonable likelihood that Chen anticipates claims 1–13, 15, and 23–29. 2. Obviousness Petitioner contends that Chen, either alone or in combination with Staab or Strobush, would have rendered claims 1–29 obvious. Pet. 37–54. Petitioner does not rely on Staab or Strobush for teaching “polymer matrix during film casting is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105 sec-1.” In fact, Petitioner does not further address this limitation in its obviousness analysis. Thus, Petitioner relies on the same inherency theory discussed above. “[T]he inherency doctrine may apply to an otherwise obvious claim as well.” Allergan, Inc. v. Sandoz Inc., 726 F.3d IPR2014-00794 Patent 8,652,378 B1 11 1286, 1294 n.1 (Fed. Cir. 2013). Petitioner’s failure to account for the shear-thinning pseudoplasticity of Chen’s polymer matrix when exposed to shear rates of 103–105 sec-1, however, similarly dooms its patentability challenge of claims 1–29 for obviousness. III. CONCLUSION For the reasons given above, the information presented in the Petition fails to establish a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one challenged claim of the ’378 patent. IV. ORDER Accordingly, it is ORDERED that the Petition is denied. FOR PETITIONER: Danielle Herritt dherritt@mccarter.com Kia Freeman kfreeman@mccarter.com FOR PATENT OWNER: Harold Fox hfox@steptoe.com Stephanie Schonewald sschonew@steptoe.com Copy with citationCopy as parenthetical citation