Preliminary Response by Patent Owner
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`IPR2016-00245
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`UNITED STATES PAENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Mr. J. Kyle and Mr. Erich Spangenbergh
`Petitioner
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`v.
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`ALPEX PHARMA
`Patent Owner
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`Patent No. 8,440,170
`Issued: May 14, 2013
`Filed: PCT January 30, 2009
`Inventors: F. Stroppolo and S. Ardalan
`Title: “Orally Disintegrating Tablets with Speckled Appearance”
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`Inter Partes Review: No. IPR2016-00245
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`MAIL STOP PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`PRELIMINARY RESPONSE BY PATENT OWNER
`UNDER 37 C.F.R. § 42.107
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`i
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION
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`II.
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`THE ‘170 PATENT
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`A. The Invention Accurately Understood
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`B. The Claimed Language Properly Construed
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`1 Orally Disintegrating Tablets
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`2. “Colored Granules”
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`III.
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`SHORTCOMINGS OF PETITIONERS’ REFERENCES
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`1
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`2
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`5
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`A. The Prevacid Label
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`1. The Prevacid Label Fails to Describe the ‘170 Patent’s Orally Disintegrating
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`Tablets (ODT)
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`2. The Prevacid Label Fails to Describe the ‘170 Patent’s “Colored Granules”
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`B. Stawski
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`1. Stawski Fails to Describe the ‘170 Patent’s ODT
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`2. Stawski Fails to Described the ‘170 Patent’s “Colored Granules”
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`C. Serpelloni
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`1. Serpelloni Fails to Describe the ‘170 Patent’s ODT
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`2. Serpelloni Fails to Describe the ‘170 Patent’s “Colored Granules”
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`IV.
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`NO REASONABLE LIKELIHOOD THAT THE ‘170’ PATENT
`CLAIMS 1-9 DEFINE SUBJECT MATTER OBVIOUS FROM
`THE PREVACID LABEL IN VIEW OF STASKI OR SERPELLONI
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`A. The Hypothesized Combination of Stawski with the Prevacid Label
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`Is Fatally Deficient
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`1. Not All the Claimed Elements Are Described
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`2. Considered in Its Entirety Stawski Would Have Led Away from
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`the ‘170 Patent’s Claimed Invention
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`3. The Hypothesized Reference Combination Would Have Rendered
`the Prevacid Label Unsatisfactory for Its Intended Purpose
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`B. The Hypothesized Combination of Serpelloni with the Prevacid
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`Label is Fatally Defective
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`1. Not All the Claimed Element Are Described
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`2. Considered in Its Entirety Serpelloni Would Have Led Away from
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`the 170’ Patent’s Claimed Invention
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`3. The Hypothesized Reference Combination Would Have Rendered
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`the Prevacid Label Unsatisfactory for Its Intended Purpose
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`C. Petitioners’ Expert Declaration is Ineffectual
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`D. Dependent Claims 2-9
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`V.
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`CONCLUSION
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`iii
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`TABLE OF AUTHORITIES
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`Cases
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`In re Suitco Surface,
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`603 F.3d 1250 (Fed. Cir. 2010)
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`In re Buszard,
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`504 F.3d 1364 (Fed. Cir. 2007)
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`KSR Int'l Co. v. Teleflex Inc.,
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`550 U.S. 538, 416 (2007)
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`Sakraida v. AG Pro, Inc.,
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`425 U.S. 273, 282 (1976)
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`Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.,
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`396 U.S. 57, 62-63 (1969)
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`6
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`16
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`16
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`Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp.,
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`340 U.S. 147, 152 (1950)
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`Kropa v. Robie,
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`187 F.2d 150, 152 (CCPA 1951)
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`In re Stencel,
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`828 F.2d 751, 4 USPQ2d 1071 (Fed. Cir. 1987)
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`W.L. Gore & Assoc., Inc. v. Garlock, Inc.,
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`721 F.2d 1540 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984)
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`United States v. Adams,
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`383 U.S. 39 (1966)
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`In re Haruna,
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`249 F.3d 1327 (Fed. Cir. 2001)
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`16
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`iv
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`I.
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`INTRODUCTION
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`Pursuant to 35 U.S.C. § 313 and 37 C.F.R. § 47.107(a), Patent Owner Alpex (“Alpex”)
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`presents this Preliminary Response (“Preliminary Response”) to the Petition for Inter Partes
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`Review (“Petition”) of U.S. Patent No. 8,440,170 (“the ‘170 Patent”) which was filed November
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`24, 2015 by Bass and Spangenberg (“Petitioners”).
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`Petitioners have not argued that any of claims 1-9 of the ‘170 Patent defines subject
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`matter anticipated by the prior art. Rather, Petitioners have patched together combination of
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`reference teachings which putatively would have made Alpex’s claimed invention unpatentable.
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`The Petition contends two grounds for deciding against the ‘170 Patent, namely: ground 1 to the
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`effect that ‘170 Patent claims 1-9 are unpatentable for obviousness on a combination of teachings
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`from two references Petitioners call “the Prevacid Label” and “Stawski”; and ground 2 to the
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`effect that ‘170 Patent claims 1-3, 5, 6, 8 and 9 are unpatentable for obviousness on a
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`combination of teachings from “the Prevacid Label” and another reference Petitioners call
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`“Serpelloni”.
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`However, grounds 1 and 2 are fatally defective because Petitioners have simply not
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`established a case of prima facie obviousness over either the Prevacid Label in view of Stawski,
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`or the Prevacid Label in view of Serpelloni. Alpex submits that the attempted reference
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`combinations are unavailing because (i) neither involves references which in the aggregate
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`describe all the elements of the ‘170 Patent claims, (ii) in any event, even if combined, the
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`references would have led away from the ‘170 Patent invention as claimed, and (iii) in reality,
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`the references cannot be properly combined under the law because the modifications to the
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`Prevacid Label which Petitioners propose in both instances results in making the Prevacid Label
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`unsatisfactory for its intended purpose.
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`1
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`Petitioners positions are further undermined by the ineffectuality of Dr. Kinam Park’s
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`Declaration (“Declaration”) submitted in support of their position. The Declaration (hereinafter
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`sometime “Decl.”) is devoid of independent support or corroboration for numerous “naked”
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`opinions set forth therein concerning critical issues in this matter.
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`The Declaration in many instances is simply a repetition of points contented by
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`Petitioners in their advocacy submission, without material elaboration. And, in some instances,
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`it appears the opinion in the Declaration are based on crucially inaccurate characterizations of the
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`reference disclosures treated. Consequently, the Declaration is not worthy of being
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`countenanced.
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`The ‘170 Patent contains independent claim 1, and dependent claims 2-9. Alpex will
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`demonstrate that the grounds for attacking patentability in the Petition are untenable as to claim
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`1. It follows that they are also untenable as to dependent claims 2-9.
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`Accordingly, denial of the Petition is solicited.
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`Please note that Alpex has confined the Preliminary Response to reversal issues which it
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`believes are justiciable based on the Petition and general public knowledge. Nevertheless, Alpex
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`is not conceding or acquiescing in any of the points made or positions taken in the Petition.
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`Alpex reserve the right to elaborate the arguments advanced herein, as we al to present additional
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`arguments and evidence (expert or otherwise) in support of its position, at other stages of the
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`proceedings; this Preliminary Response is without prejudice to the foregoing.
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`II.
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`THE ‘170 PATENT
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`Petitioners’ flawed attack on the ‘170 Patent derives seminally from misapprehension of
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`the patented invention.
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`2
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`A.
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`The Invention Accurately Understood
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`The “Overview” presented in the Petition at pages 3-4 is simplistic to a fault. Petitioners’
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`representation that the ‘170 Patent has to do with “orally disintegrating tablets with speckled
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`appearances” (Petition, p. 3) crucially understates the complexity of the problem giving rise to
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`Alpex’s invention and the ingenuity of the patented solution. More specifically, as explained in
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`the ‘170 Patent’s specification, the problem faced by the inventors was that – when dealing with
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`an orally disintegrating tablet (“ODT”) – conventional options for identifying and differentiating
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`it from other ODTs have been disadvantageously constrained. Thus, in the case of an ODT
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`physical identification methods are limited because ODT tablets are characterized by
`a low hardness which allows their rapid dissolution with in contact with saliva.
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`(Col. 1, ll 47-50). As a consequence, encasing the ODT ingredients in a film or coating,
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`on which distinguishing indicia can be applied, has proved unsatisfactory. This is because “it
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`could delay saliva penetration in the tablets, so delaying their disintegration” (Id., ll. 52-53).
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`Therefore,
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`identification of ODT by printing is also unusual because this technique requires a
`smooth and shining tablet surface, such as a film- or sugar- coated tablet.
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`(Id., ll. 54-56). Additionally, embossing is impractical since the characters are
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`usually too small, due to the limited tablet surface, to be easily read by elderly people
`or by people with limited vision.
`(Id., ll. 57-59). Moreover, typical coloring protocols are unavailing as
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`pharmaceutically acceptable colors make difficult to obtain an ODT easily
`identifiable over conventional colored tablets.
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`(Id., ll. 60-62).
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`The ‘170 Patent’s inventors have solved the very basic but important problem described
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`above by incorporating colored beads in the ODT, whereby a bicolored system featuring spots
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`that contrast in color with the rest of the ODT is provided.
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`However, the solution was more complicated that meets the eye. The very properties of
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`ODTs which make them popular, i.e., they
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`dissolve in the oral cavity by contact with saliva, do not require water for ingestion
`and could permit a buccal absorption of the active ingredient
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`(Id., ll. 38-41), must not be impaired through incorporation of the “colored beads”. The patented
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`Invention constitutes recognizing that to implement the incorporation of colored beads while
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`preserving the favorable properties of ODTs
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`the colored beads must be soluble and dissolve as fast as the tablets to avoid an
`unpleasant grinding sensation when the tablet disintegrates in the oral cavity…the
`colored beads must be stable, i.e., they must not release the color during storage, and
`[the beads] should give minimal coloration of the oral cavity after disintegration of
`the tablet.
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`(Col. 2, ll. 9-14).
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`Accordingly, the invention comprises ODT containing, as the essential “colored beads”
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`described heretofore, “colored granules of a water-soluble sugar”.
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`These are not just any particles, but more exclusively “granular particles of a water-
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`soluble sugar”. The term “colored granules” as used in the ‘170 Patent “means granules of a
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`color different from the color of the tablet.” Among other things, the colored granules must
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`“dissolve as fast as the tablets” (i.e., no less fast) to avoid becoming an unwanted residuum in the
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`mouth. As further taught in the specification
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`Preferably the colored granules useful for the ODT with speckled appearance of the
`present invention are prepared by granulation of the water-soluble sugar with an
`aqueous suspension or solution of the coloring agent in a suitable fluid bed
`granulator.
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`(col. 3, ll. 10-14).
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`The invention to which the ‘170 Patent is directed cannot be understood accurately unless
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`the foregoing is taken into account.
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`B.
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`The Claimed Language Properly Construed
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`In furtherance of Patent Owner’s attempt to focus this submission, the following
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`discussion is confined to two critical errors in claim construction may by Petitioners. However,
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`the Preliminary Response is without prejudice to Patent Owner’s relying on further or other
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`bases for disputing incorrect construction of any claim or claims of the ‘170 Patent.
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`1
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`Orally Disintegrating Tablets
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`Petitioners concede that in inter partes review proceedings “a claim term is given
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`‘its broadest reasonable interpretation in light of the specification” (Petition, p. 8), taking into
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`account how it would be “understood by one of ordinary skill in the art” (Kim Decl., p. 5 ¶13).
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`Judged by this standard, the expression “orally disintegrating tablet” in the ‘170 Patent claim
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`language means one that dissolves in the mouth (without requiring water for ingestion) such that
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`absorption of the active ingredient can occur there. The alternative construction advanced by
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`Petitioners, which is necessary to the hypothesized prima facie case of obviousness, exceeds the
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`proper bounds of the expression in issue and is therefore incorrect.
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`More specifically, the ‘170 Patent’s specification explicitly identifies what it means by
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`the expression ‘orally disintegrating tablet”. In lines 38-41 of column 1, it si prescribed that
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`Orally Disintegrating Tablets (ODT) dissolve in the oral cavity by contact with saliva,
`do not require water for ingestion and could permit a buccal absorption of the active
`ingredient.
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`Thus, when that expression appears in the claims, it must under the law be given a
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`construction which is consistent with the specification. It follows that reference to “orally
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`disintegrating tablets” in the patent language must mean tablets which dissolve in the oral cavity
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`by contact with saliva, break down sufficiently in the oral cavity that water is not required for
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`ingestion, and make the tablet’s active ingredient component available for buccal absorption.
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`This is mandated by applicable case precedent. Attention is invited to In re Suitco
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`Surface, 603 F.3d 1250 (Fed. Cir. 2010), and In re Buszard, 504 F.3d 1364 (Fed. Cir. 2007). In
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`Suitco, when interpreting the phrase “material for finishing the top surface of the floor”, the
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`Court discounted the argument that the material could “fall anywhere above the surface being
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`finished”, with “several layers…place on top of the finished layer” if desired. Instead, it was
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`ruled that the phrase in question should be read in light of the specification as it would be
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`interpreted by one of ordinary skill in the art to mean “a layer on the top surface of a
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`floor…[and] not any intermediate, temporary or transitional layer”. Similarly, Buszard involved
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`the issue of whether pending claim language – “flexible polyurethane foam reaction mixture” –
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`should be construed to encompass “any reaction mixture which produces, at least ultimately, a
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`flexible polyurethane foam”. It was argued the claim language should be assigned that latter
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`meaning because it was the broadest reasonable interpretation. However, the Court disagreed,
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`observing that the specification and claims specifically state “the requirement of a flexible
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`polyurethane foam reaction mixture” and that [no] matter how broadly ‘flexible foam reaction
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`mixture’ is construed, it not a rigid foam reaction mixture”. Since one of ordinary skill “knows
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`that a flexible foam and a rigid foam have different” characteristics, the claim had to be read
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`accordingly.
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`In the Petition, the governing legal principle espoused by Petitioners for claim language
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`construction is ignored on the question of properly defining “orally disintegrating tablets”.
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`Petitioners blithely proceed on the basis that any product referred to as “an orally disintegrating
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`Preliminary Response by Patent Owner
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`tablet” is encompassed by the patent claim language without examining the features of such
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`product to ascertain whether they correspond to those delineated in the ‘170 Patent. For
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`instance, at pages 13, 19 and 24 of the Petition, it is contended that the expression “orally
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`disintegrating tablets” as recited in the 170 Patent claim language encompasses “Delayed-
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`Release Orally Disintegrating Tablets”. The Petition is devoid of any evaluation as to whether
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`the delayed-release ODT fulfills the patent claim requirements for (i) disintegration in the oral
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`cavity, (ii) without need for water to ingest the tablet, (iii) such that the active ingredient’s
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`“buccal” absorption (i.e., absorption in the mouth) is permitted. This includes Dr. Parks’ naked
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`opinion which, without support, concludes disclosure of a delayed-release ODT meets the patent
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`claim language. (Park Decl., ¶¶ 14-15, pp. 5-6). Patent Owner submits to be self-evident that a
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`delayed-release ODT, such as discussed on pages 13, 19 and 24 of the Petition – which delayed-
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`release ODT (though Petitioners omit to mention the point) is designed to deliver an active
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`ingredient not absorbed in the mouth but instead after it leaves the stomach – need to disintegrate
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`in the oral cavity to the extent required for buccal absorption of the active ingredient. That
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`characteristic is irrelevant to the described operation of a delayed-response ODT, and there is no
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`recognition the Prevacid Label product need to enable buccal absorption, or analysis by
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`Petitioners of why the reference disclosure would be certain to enable buccal absorption.
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`Accordingly, Petitioner’s construction of “orally disintegrating tablets” is unfounded and
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`untenable. (Indeed, it is reasonably inferred that the shortcomings of this approach to construing
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`“orally disintegrating tablets” were apparent even to Petitioners; on a number of occasions in the
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`Petition where they quote the phrase “Delayed-Release Orally Disintegrating Tablet” only the
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`words “Orally Disintegrating Tablet” – but not “Delayed Release” – are underscored, indicating
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`a realization that drawing attention away from “Delayed-Release is desirable).
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`2
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`“Colored Granules”
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`Again, in construing the expression “colored granules”, Petitioners have declined
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`to abide their own statement of the governing law, and therefore have advanced an incorrect
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`characterization of the claim term’s meaning.
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`Taking the expression “colored granules” in light of the ‘170 Patent specification as
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`understood by one of ordinary skill, Alpex submits it has a more nuanced meaning that may at
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`first appear. Thus, the ‘170 Patent specification calls for incorporation in an ODT of “colored
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`beads” that are “soluble and dissolve as fast as the tablets to avoid an unpleasant grinding
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`sensation when the tablet disintegrates in the oral cavity”. (Col. 2, ll. 9-11). It is further
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`specified that the “colored beads” are stable, i.e., they must not release the color during storage,
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`and should give minimal coloration of the oral cavity after disintegration of the tablet”. (Id., ll.
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`12-14). The invention’ objectives are indicated to be achieved by incorporation of such colored
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`beads in the nature of “colored granules”, which are a “different color from the color of the
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`tablet”. (Id., ll. 25-29). The soluble colored beads are “soluble colored granules [which] are
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`granular particles of a water-soluble sugar” (emphasis supplied). (Id., ll. 35-36).
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`It is all-important in construing the word “granules” to understand that pursuant to the
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`‘190 Patent’s specification, it is not coextensive with the term “particles”. Granules are adhered
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`agglomerates of individual particles. This flows from the specification’s clear instructions that
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`“colored granules” are not merely any particles, but more precisely the subset “granular
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`particles”. The specification’s guidance is that such granular particles can be “prepared by
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`granulation of the water-soluble sugars” (col. 3, line 10 et seq.). Granulation is typically
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`understood to mean in general technological parlance to mean “the act or process in which
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`primary powders particles are made to adhere to from larger, multiparticles entities called
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`8
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`Preliminary Response by Patent Owner
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`IPR2016-00245
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`granules”, as corroborated by the annexed entry from Wikipedia (which source is cited to
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`indicate the ubiquity of the understanding, without introducing expert testimony on the subject,
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`an option not available to Alpex at this juncture).
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`Therefore, the meaning to be accorded “colored granules” as used in the ‘170 Patent
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`claim language must be discerned from the specification as understood by one of ordinary skill
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`in the art. In re Suitco Surface, supra; In re Buszard, supra. The proper construction of “colored
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`granules” is granular particles (i.e., larger multi-particle entities which are colored differently
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`from the rest of the ODT).
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`Petitioners’ effort to transmute the proper meaning of “granule” as discussed in this
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`submission into a “small particle” without further qualification is contrary to the governing law –
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`not to mention Petitioners’ own characterization of that law. It is not clear where Petitioners’
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`statement “the term ‘granule’ means ‘a small particle’” (p. 9 of the Petition) finds basis. No
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`support is cited for its first appearance (opening two lines) on that page. The only attempted
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`justification for taking “granule” to mean “a small particle” is a citation to The American
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`Heritage Dictionary (3d. Ed.) (1993), which says “granules” means a “small grain or pellet, a
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`particle”. But the use selected by Petitioners does not align with the sense of the ‘170 patent
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`specification. There, a granule is said to be a special kind of particle, namely, a “granular
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`particle”, which as pointed out previously, constitutes adhered agglomerate of discrete particles –
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`ant not the discrete particles themselves individually.
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`To find that “granular particle” as used in the ‘170 Patent is coextensive with “a small
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`particle” would be illogical, as the word “granular” – interpreted in accordance with Petitioners’
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`argument – would be redundant (a particulate particle”) or at least superfluous. Rather, if effect
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`is given to inclusion of the word “granular” it must have a meaning beyond “particle”. In this
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`regard, see In re Suitco Surface, supra, and In re Buszard, supra in preceding subpart 1.
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`To reflect the specification accurately, as it would reasonably be understood by one of
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`ordinary skill, independent effect must be given to “granular”. Petitioners’ omission to do
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`compels a conclusion that the proffered definition “a small particle” in incorrect.
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`III.
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`SHORTCOMINGS OF PETITIONERS’ REFERENCES
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`The three references upon which Petitioners’ rely are identified on page 10 of the
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`Petition:
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`(i)
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`The Prevacid Label, descriptive material regarding (inter alia) PREVACID
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`(lansoprazole) Delayed-Release Orally Disintegrating Tablets, putatively
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`“published in June 2007” (“the Prevacid Label”);
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`(ii)
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`Stawski et al. U.S. Publication No. 2006/0193909 entitled “Breath Freshening
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`Presses Tablets and Methods of Making Same”; (“Stawski”); and
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`(iii)
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`Serpelloni U.S. Patent No. 4,744,991 entitled “Speckled Sugarless Chewing Gum
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`and Process for Its Manufacture” (“Serpelloni”).
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`The rationale for combining the references in support of Petitioners’ challenge to the ‘170
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`Patent is that claims 1-9 “are unpatentable as obvious over the Prevacid Label in view of
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`Stawski, and further claims 1-3, 5, 6, 8 and 9 “are unpatentable as obvious over the Prevacid
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`Label in view of Serpelloni” (Petition, p. 11). As will be explained infra, the Petition fails to
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`establish a prima facie case of obviousness because the hypothesized combinations of reference
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`teachings are inadequate, or prohibited, under the law on obviousness. However, even
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`Petitioners’ contentions as to each reference considered separately are erroneous, and this section
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`is devoted to exposing such error, since it carries forward into and contaminates Petitioners’
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`ultimate arguments on putative obviousness.
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`A.
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`The Prevacid Label
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`The Prevacid Label describes, inter alia, PREVACID for Delayed-Release Orally
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`Disintegrating Tablets. Each delayed-release orally disintegrating tablet contains enteric-coated
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`microgranules consisting of lansoprazole (the active ingredient) and inactive ingredients in the
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`nature of a carrier, including mannitol. However, there are no colored granules described in the
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`Prevacid Label, whether of mannitol or other water-soluble sugar. (Petitioners admit at page 13
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`the Prevacid Label is silent with regard to “speckles comprising colored granules of a water-
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`soluble sugar”.) Additionally, it is important to note that the Prevacid Label tablet is designed
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`for absorption of lansoprazole not in the oral cavity, but to begin only after the coated micro-
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`granules leave the stomach (e.g., page 1, paragraphs 6 and 8).
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`1
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`The Prevacid Label Fails to Describe the ‘170 Patent’s Orally
`Disintegrating Tablets (ODT)
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`As established in Section II (A), supra, the term “orally disintegrating tablet” as
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`appears in the ‘170 Patent claim language is properly construed to mean ODTs which dissolve in
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`the oral cavity by contact with saliva, break down sufficiently in the oral cavity that water is not
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`required for ingestion, and enable buccal absorption of the ODT’s active ingredient.
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`But, the Prevacid Label is devoid of description of “an orally disintegrating tablet”
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`consistent with the claim interpretation required for the ‘170 Patent.
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`On the contrary, the Prevacid Label describes that Prevacid SolutTab Delayed-Release
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`Orally Disintegrating Tablets contain enteric-coated micro-granules of lansoprazole, the active
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`ingredient. The active ingredient’s absorption is not intended to take place in the oral cavity, but
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`instead begins only after the granules leaves the stomach (e.g., last paragraph on page 1 of 11).
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`In fact, even though it is called an orally disintegrating tablet, the active ingredient mixed into
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`the Prevacid Label ODT contains an enteric-based coating, which is resistant to the action of
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`saliva (whereby delivery of the active ingredient to and through the stomach is fostered). This
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`coating pervades the Prevacid Label ODT, and is counterproductive inasmuch as it could tend to
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`impede disintegration in the mouth. In contrast, the ‘170 patent discourages the presence of a
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`“coating”, as it could delay saliva penetration of the tablets, and their disintegration (e.g., col. 1,
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`ll. 52-53). The thrust of the Prevacid Label’s disclosure would thus have been seen as oblivious
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`to securing the properties which animate the ODT prescribed in the ‘170 Patent claims.
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`Moreover, in the ‘170 Patent it is recommended that the tablet is to be placed on the
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`tongue and allowed to disintegrate “with or without water”. The tablet is reported typically to
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`disintegrate in less than 1 minute – but for intestinal or other post-stomach absorption, not buccal
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`absorption. Again, the reference is oblivious to attainment of the expedited complete
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`disintegration in the oral cavity needed for the ‘170 Patent’s invention. So, the Prevacid Label
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`ODT is designed for a different function, and is a different animal, from the ‘170 Patent’s ODT.
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`It follows that the Prevacid Label fails to describe the ‘170 Patent’s ODT as claimed,
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`namely, one which dissolves in the oral cavity by contact with saliva (without the need for water)
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`such that buccal absorption is enabled.
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`2
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`The Prevacid Label fails to Describe the ‘170 Patent’s “Colored
`Granules”
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`The Prevacid Label is missing any disclosure of the ‘170 Patent’s “colored
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`granules of a water-soluble sugar”. Instead, the reference teaches “white to yellowish white”
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`tablets having “orange to dark brown speckles”, and in the Declaration it is represented that such
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`tablet “‘has the look of being covered with small spots or patches of color’” (¶13, p. 5).
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`However, contrary to Petitioners’ contention at page 13 of their submission, the Prevacid Label
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`does not teach “speckles comprising colored granules”, especially as that term is used in the ‘170
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`Patent (see Section II (B), supra). There is absolutely no mention in the Prevacid Label of
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`speckles comprising “colored granules” of a water-soluble sugar, i.e., an adhered agglomerate of
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`sugar particles, per Section II (B). In any event, Petitioners admit that the Prevacid Label does
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`not disclose “speckles comprising colored granules of a water-soluble sugar”.
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`B.
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`Stawski
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`Stawski is generally directed to pressed tablets having an abrasive surface suitable for
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`scrubbing the top surface of the human tongue (e.g., p.1, ¶[0002]), but is inadequate to provide
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`the ‘170 patent claim elements absent from the Prevacid Label.
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`1
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`Stawski Fails to Describe the ‘170 Patent’s ODT
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`As explained on col. 2, lines 9-11 of the ‘170 patent,
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`“In case of ODT, the colored beads must be soluble and dissolve as fast as the
`tablets to avoid an unpleasant grinding sensation when the tablet disintegrates in
`the oral cavity”.
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`Unlike the ‘170 Patent’s ODT, the tablets described in Stawski are “pressed” and have
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`“an abrasive surface that is suitable for scrubbing the top surface of the tongue” (e.g., Stawski
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`p.1, ¶¶[0002] and [0009]). The abrasive surface can be formed by incorporating abrasive
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`inclusions on or in the tablet’s matrix; the inclusions are “less soluble than the surrounding
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`matrix” (Id., p.2, ¶[0052]. Put another way, the Stawski tablet is one in which the inclusions
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`survive disintegration, not one designed to leave no inclusion residuum.
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`Therefore, Stawski not only fails to disclose an ODT with inclusions which dissolve at
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`least as fast as the matrix in which they are located, it actually teaches inclusions which are
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`intended to dissolve less rapidly than the rest of the tablet. Stawski is thus antithetical to the
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`‘170 Patent’s requirement for an ODT which has dissolved fully by the time the tablet
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`disintegrates in the oral cavity (e.g., col. 2, lines 9-11).
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`Accordingly, the tablets described by Stawski are not the ODT of the ‘170 Patent, but
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`rather function differently for a different purpose.
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`2
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`Stawski Fails to Describe the ‘170 Patent’s “Colored Granules”
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`While Stawski may mention “abrasive inclusions … [providing] an abrasive
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`surface”, which “abrasive inclusions may be made from a number of different materials,
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`including crystalline sugars or polyols” (e.g., ¶¶ [0052] and [0085],) this is only a superficial and
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`incomplete characterization of the reference’s import. In reality, Stawski fails to constitute a
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`proper description of the ‘170 Patent’s “colored granules”.
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`As established in the immediately preceding subpart (A), the inclusions disclosed in
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`Stawski are abrasive, and dissolve less rapidly than the surrounding matrix. This is directly
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`contrary to the requirement in the ‘170 patent that its “colored granules” dissolve at least as fast
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`as the rest of the ODT. Thus, Stawski’s colored granules, abrasive inclusions that survive
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`dissolving of the balance of the pressed tablet, cannot be the “colored granules” of the ‘170
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`patent.
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`C.
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`Serpelloni
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`Serpelloni is directed to sugarless speckled chewing gum in which are incorporated
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`sweetener particles to impart flavor (e.g., col. 1, lines 6-7).
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`1
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`Serpelloni Fails to Describe the ‘170 Patent’s ODT
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`As commonly known, chewing gum is a soft, cohesive substance designed for
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`chewing but not for swallowing. Moreover, it does not dissolve in the oral cavity when in
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`contact with the saliva.
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`Thus, chewing gum is effectively the opposite of an ODT, as chewing gum is never
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`meant to dissolve in the oral cavity.
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`Accordingly, the chewing gum described by Serpelloni fails to exhibit any of the features
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`defining the ODT of the ‘170 patent as extensively discussed supra.
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`2
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`Serpelloni Fails to Describe the ‘170 Patent’s “Colored Granule