Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 13
`
` Entered: May 20, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`J. KYLE BASS and ERICH SPANGENBERG,
`Petitioners,
`
`v.
`
`
`
`ALPEX PHARMA SA,
`Patent Owner.
`____________
`
`Case IPR2016-00245
`Patent 8,440,170 B2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 13
`
` Entered: May 20, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`J. KYLE BASS and ERICH SPANGENBERG,
`Petitioners,
`
`v.
`
`
`
`ALPEX PHARMA SA,
`Patent Owner.
`____________
`
`Case IPR2016-00245
`Patent 8,440,170 B2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00245
`Patent 8,440,170 B2
`
`
`INTRODUCTION
`I.
`Messrs. J. Kyle Bass and Erich Spangenberg (“Petitioner”) filed a
`Corrected Petition requesting an inter partes review of claims 1–9 of U.S.
`Patent No. 8,440,170 B2 (Ex. 1001, “the ’170 patent”). Paper 5 (“Pet.”).
`Alpex Pharma SA (“Patent Owner”) filed a Corrected Preliminary Response
`to the Petition. Paper 12 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” Upon considering the Petition and the
`Preliminary Response, we determine that Petitioner has shown a reasonable
`likelihood that it would prevail in showing the unpatentability of claims 1–3,
`5, 6, 8, and 9. Accordingly, we institute an inter partes review of those
`claims.
`
`Related Proceedings
`A.
`Neither Petitioner nor Patent Owner identifies any related matters.
`See, e.g., Pet. 2 (“Petitioner is unaware of any other matter related to the
`’170 patent”).
`
`The ’170 Patent (Ex. 1001)
`B.
`The ’170 patent issued on May 14, 2013, with Federico Stroppolo and
`
`Shahbaz Ardalan as the listed co-inventors. Ex. 1001. As set forth in the
`’170 patent, “the invention relates to orally disintegrating tablets with
`speckled appearance for easy identification by physicians, nurses and
`patents.” Id. at 1:13–16. According to the ’170 patent:
`
`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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`
`The advantageous properties of ODT over conventional tablets
`are making them always more and more popular for drug
`administrations.
`Id. at 1:38–43.
`
`The ’170 patent teaches that the use of solid or semisolid forms
`having a speckled appearance is common in cosmetic and laundry products,
`such as toothpastes and soaps, with the speckled appearance being achieved
`by incorporating a colored bead comprised of a different material into the
`composition. Id. at 2:4–8. For ODT, the ’170 patent teaches that 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. Moreover, the colored beads
`must be stable, i.e. they must not release the color during storage,
`and should give minimal coloration of the oral cavity after
`disintegration of the tablet.
`Id. at 2:9–14.
`
`The ’170 patent teaches that the speckled appearance is achieved by
`using colored granules of a water-soluble sugar, such as sucrose or sorbitol,
`which are mixed with a pharmaceutically acceptable carrier in the
`preparation of the ODT. Id. at 2:20–39. The colored granules “have a
`particle size from about 10 µm to about 1200 µm, preferably from about 200
`µm to about 800 µm, most preferably from about 300 µm to about 500 µm.”
`Id. at 2:55–58. According to the ’170 patent, the “particle size of the colored
`granules is critical,” as “[c]olored granules with too small particle size are
`not visible,” and will not provide a speckled appearance, whereas “the use of
`colored granules with too large particle size results in a tablet which appears
`uniformly colored.” Id. at 2:49–54.
`
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`Patent 8,440,170 B2
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`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–9 of the ’268 patent. Claim 1 is the
`only independent claim, is illustrative of the challenged claims, and is
`reproduced below:
`tablets with speckled
`1. An orally disintegrating
`appearance comprising
`(a) speckles comprising
`colored granules of a water-soluble sugar, and (b) a
`pharmaceutically acceptable carrier.
`
`
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–9 of the ’268 patent
`on the following grounds (Pet. 11):
`
`References
`Prevacid Label®1 and Stawski2
`Prevacid Label and Serpelloni3
`
`Basis
`§ 103(a)
`§ 103(a)
`
`Claims Challenged
`1–9
`1–3, 5, 6, 8, and 9
`
`Petitioner relies also on the Declaration of Kinam Park, Ph.D. Ex. 1002.
`
`
`1 PREVACID® (lansoprazole) Delayed-Release Capsules; PREVACID®
`(lansoprazole) For Delayed-Release Oral Suspension; PREVACID®
`SoluTab™ (lansoprazole) Delayed-Release Orally Disintegrating Tablets,
`Medicine Online (June 2007), http://www.medicineonline.com/drugs/p/
`3694/PREVACID-lansoprazole-Delayed-Release-CapsulesPREVACID-
`lansoprazole-For-Delayed-Release-Oral-SuspensionPREVACID-SoluTab-
`lansoprazole-Delayed-Release-Orally-Disintegrating-Tablets.html
`(Ex. 1004) (“Prevacid® Label”).
`2 Stawski et al., Pub. No. US 2006/0193909 A1, published Aug. 31, 2006
`(Ex. 1005) (“Stawski”).
`3 Serpelloni, U.S. Patent No. 4,744,991, issued May 17, 1988 (Ex. 1006)
`(“Serpelloni”).
`
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`Patent 8,440,170 B2
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`
`II. ANALYSIS
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable constructions in light of
`the Specification of the patent in which they appear. See 37 C.F.R.
`§42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed.
`Cir. 2015) (“Congress implicitly approved the broadest reasonable
`interpretation standard in enacting the AIA,” and “the standard was properly
`adopted by PTO regulation.”), cert. granted sub nom. Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 890 (2016) (mem.) (No. 15-446). Under the broadest
`reasonable construction standard, claim terms are presumed to have their
`ordinary and customary meaning, as would be understood by one of ordinary
`skill in the art in the context of the entire disclosure. In re Translogic Tech.,
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`“Orally Disintegrating Tablets”
`i.
`Patent Owner contends that “orally disintegrating tablets” should be
`construed as “one that dissolves in the mouth (without requiring water for
`ingestion) such that absorption of the active ingredient can occur there.”
`Prelim. Resp. 7. Specifically, Patent Owner points to the following teaching
`of the ’170 patent:
`
`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.
`Id. (quoting Ex. 1001, 1:38–41).
`Based on the above quoted language and citing In re Suitco Surface,
`
`603 F.3d 1255 (Fed. Cir. 2010), and In re Buszard, 504 F.3d 1364 (Fed. Cir.
`2007), Patent Owner argues that “orally disintegrating tablets” “must mean
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`tablets which dissolve in the oral cavity by contact with saliva, break down
`sufficiently in the oral cavity [such] that water is not required for ingestion,
`and make the tablet’s active ingredient component available for buccal
`absorption.” Id. at 8. Such a construction, Patent Owner argues, does not
`encompass a delayed-release orally disintegrating tablet. Id. at 9.
`
`We decline to construe the claims as suggested by Patent Owner.
`Specifically, Patent Owner does not point us to anything in the claims, or the
`Specification of the ’170 patent, that requires dissolution of the tablet in the
`mouth such that buccal absorption of the active ingredient occurs. The
`portion of the Specification relied upon by Patent Owner to read the
`limitation of buccal absorption into the claims, quoted above, states that the
`orally disintegrating tablets “could permit a buccal absorption of the active
`ingredient.” Ex. 1001, 1:38–41 (emphasis added). “Could” does not mean
`“must” in this context, but is used to express possibility.4 The use of
`“could,” therefore, suggests that although buccal absorption may occur, it is
`not required. Thus, for purposes of this decision, we construe “orally
`disintegrating tablets” as “tablets that dissolve in the oral cavity by contact
`with saliva, without the need for water for ingestion.”
`“Colored Granules”
`ii.
`Petitioner argues that the Specification teaches that the granules have
`a particle size from about 10 µm to about 1200 µm. Pet. 9. Thus, Petitioner
`asserts that “colored granules” should be construed as “small particles of a
`size from about 10 µm to about 1200 µm having or having been given
`color.” Id.
`
`
`4 Could Definition, Dictionary.com, http://www.dictionary.com/browse/
`could (last visited May 18, 2016).
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`Patent Owner responds that the “proper construction of ‘colored
`
`granules’ is granular particles (i.e., larger multi-particle entities which are
`colored differently from the rest of the ODT).” Prelim. Resp. 12. Patent
`Owner asserts that Petitioner’s construction of “granule” as a “small
`particle” is not supported by the Specification. Id. at 12–13.
`In particular, Patent Owner notes that the Specification requires that
`the “‘colored beads’ . . . are ‘soluble and dissolve as fast as the tablets to
`avoid an unpleasant grinding sensation when the tablet disintegrates in the
`oral cavity.’” Id. at 11 (quoting Ex. 1001, 2:9–11). Moreover, Patent Owner
`asserts that the Specification further specifies “that the ‘colored beads’ are
`stable, i.e., they must not release the color during storage, and should give
`minimal coloration of the oral cavity after disintegration of the tablet.” Id.
`(quoting Ex. 1001, 2:12–14). According to Patent Owner, those objectives
`are achieved by “soluble colored beads [that] are ‘soluble colored granules
`[which] are granular particles of a water-soluble sugar.’” Id. (second
`alteration in original) (quoting Ex. 1001, 2:35–36).
`
`Patent Owner asserts further that the term “granule” is not coextensive
`with the term “particle.” Id. According to Patent Owner,
`Granules are adhered agglomerates of individual particles. This
`flows from the specification’s clear instructions that “colored
`granules” are not merely any particles, but more precisely the
`subset “granular particles”. The specification’s guidance is that
`such granular particles can be “prepared by granulation of the
`water-soluble sugars” (col. 3, line 10 et seq.). Granulation is
`typically understood to mean in general technological parlance
`to mean “the act or process in which primary powders particles
`are made to adhere to from larger, multiparticles entities called
`granules”, as corroborated by the annexed entry from Wikipedia
`(which source is cited to indicate the ubiquity of the
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`understanding, without introducing expert testimony on the
`subject, an option not available to Alpex at this juncture).
`Id. at 11–12.
`
`For purposes of this decision, we construe “colored granules” as
`“small particles of a size from about 10 µm to about 1200 µm having or
`having been given color, wherein the granules are colored differently from
`the remainder of the tablet.” We have considered Patent Owner’s argument
`that “granule” should be construed as a “multi-particulate entity,” but do not
`find that construction to be supported by the Specification of the ’170 patent.
`
`Patent Owner relies on the disclosure in the ’170 patent that the
`“colored granules are granular particles of a water-soluble sugar such as
`sucrose or a polyalcohol.” Ex. 1001, 2:35–36. That teaching, however, does
`not unambiguously state that the “granules” are aggregates of smaller
`particles.
`
`Moreover, other parts of the disclosure appear to equate “granule” and
`“particle.” Specifically, the ’170 patent teaches that the colored granules
`“have a particle size from about 10 µm to about 1200 µm, preferably from
`about 200 µm to about 800 µm, most preferably from about 300 µm to about
`500 µm.” Id. at 2:55–58. The ’170 patent teaches further that the “particle
`size of the colored granules is critical,” as “[c]olored granules with too small
`particle size are not visible,” and will not provide a speckled appearance,
`whereas “the use of colored granules with too large particle size results in a
`tablet which appears uniformly colored.” Id. at 2:49–54.
`
`If the term “granule” were to be construed as an aggregate of
`particles, as Patent Owner would have us do, it is unclear how the teaching
`of the size of the particle size would be applicable to the size of the granule.
`Rather, that portion of the Specification infers that the size of the granule is
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`the size of the particle, thus equating the term “granule” with “particle.” The
`’170 patent teaches further that the particle size is “critical,” because the use
`of particles that are too small may result in no speckling, whereas the use of
`too large particles results in a tablet that is uniformly colored. Notably, the
`’170 patent does not discuss how the particles may be aggregated to obtain
`the required speckled appearance of the tablet.
`Other Claim Terms
`iii.
`We determine that, for purposes of this Decision, none of the
`remaining terms in the challenged claims require express construction at this
`time. See, e.g. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999) (noting that only claim terms that are in controversy
`need to be construed, and then only to the extent necessary to resolve the
`controversy).
`
`B.
`
`Overview of Art Cited by Petitioner
`Overview of Prevacid® Label (Ex. 1004)
`i.
`The Prevacid® Label discusses Prevacid® Delayed-Release Capsules,
`
`Delayed-Release Oral Suspension, and Delayed-Release Orally
`Disintegrating Tablets. Ex. 1004, 1.5
`
`As to the delayed-release orally disintegrating tablets, the Prevacid®
`Label teaches:
`tablet contains
`Each delayed-release orally disintegrating
`enteric-coated microgranules consisting of 15 mg or 30 mg of
`lansoprazole (active ingredient) and the following inactive
`ingredients: lactose monohydrate, microcrystalline cellulose,
`magnesium carbonate, hydroxypropyl cellulose, hypromellose,
`titanium dioxide, talc, mannitol, methacrylic acid, polyacrylate,
`
`
`5 The page numbers refer to the page numbers added by Petitioner at the
`bottom of the pages of the exhibit.
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`
`polyethylene glycol, glyceryl monostearate, polysorbate 80,
`triethyl citrate,
`ferric oxide, citric acid, crospovidone,
`aspartamePhenylketonurics: Contains Phenylalanine 2.5 mg per
`15 mg Tablet and 5.1 mg per 30 mg Tablet., artificial strawberry
`flavor and magnesium stearate.
`
`Id.
`According to the Prevacid® Label, the enteric-coated microgranules
`
`allow for absorption of lansoprazole to begin after the capsules leave the
`stomach. Id. The tablet is not meant to be chewed, but should be placed on
`the tongue and allowed to disintegrate, with or without water. Id. at 10. The
`tablets usually dissolve within a minute. Id. The tablets are “white to
`yellowish white uncoated tablets with orange to dark brown speckles.” Id.
`ii.
`Overview of Stawski (Ex. 1005)
`Stawski is drawn to “confectionary products having breath freshening
`
`attributes,” and in particular, “to pressed tablets having an abrasive surface
`that is suitable for scrubbing the top surface of the human tongue.” Ex. 1005
`¶ 2. As taught by Stawski, “[e]xemplary pressed tablets retain their shape in
`the mouth and slowly dissolve.” Id. ¶ 9.
`
`Stawski teaches that the abrasive surface may be provided by abrasive
`particles, which Stawski also refers to as inclusions. Id. ¶ 52. Stawski
`teaches:
`[T]he inclusions will typically be hard particles of at least 100
`microns, preferably at least 200 microns, and most preferably at
`least 400 microns in size, and which are less soluble than the
`surrounding matrix. The inclusions may be present on the
`surface to begin with, or may be exposed as the product is
`dissolved in the mouth to produce a perceivably rough surface.
`
`Id.
`
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`As taught by Stawski, the inclusions may be made from a number of
`
`different materials, including crystalline sugars or polyols, and may contain
`flavors and/or colors. Id. ¶ 85.
`iii. Overview of Serpelloni (Ex. 1006)
`
`Serpelloni is drawn to “a speckled sugarless chewing-gum.” Ex.1006,
`1:7–8. Serpelloni teaches that “[t]he speckled appearance is generally
`obtained by means of solid sweetening particles, colored and possibly
`flavored.” Id. at 1:29–31.
`
`According to Serpelloni, when sweetener particles are colored by a
`water-soluble dye, the dye can diffuse into the mass of the chewing gum. Id.
`at 1:67–2:2. In order to prevent that diffusion, the particles of Serpelloni are
`encapsulated using a water-insoluble coating, such as a “food grade shellac
`type.” Id. at 2:16–19. Specifically, Serpelloni teaches that the “colored
`particles are constituted essentially of sorbitol,” and may be sweetened
`and/or flavored. Id. at 1:36–44. The particles also comprise at least one
`confining agent, which may be a food grade fatty acid, such as stearate, and
`in particular, magnesium stearate, and a food grade conventional emulsifier,
`such as fatty acid esters. Id. at 2:36–44. The particles are “generally from
`500 to 1500 µm and more particularly from 800 to 1200 µm.” Id. at 1:45–
`46.
`
`C. Obviousness over Prevacid® Label (Ex. 1004)
`and Serpelloni (Ex. 1006)
`Petitioner contends that claims 1–3, 5, 6, 8, and 9 are rendered
`obvious by the combination of the Prevacid® Label and Serpelloni. Pet. 23–
`31. Patent Owner disagrees. Prelim. Resp. 13–17, 20–24, 29–32.
`
`Petitioner relies on the Prevacid® Label for teaching an orally
`disintegrating tablet that has a speckled appearance. Pet. 23–24. Petitioner
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`notes further that the Prevacid® Label teaches the use of a pharmaceutically
`acceptable carrier. Id. at 25–26. According to Petitioner, the Prevacid®
`Label teaches that the tablets contain mannitol, “but does not specifically
`disclose speckles comprising colored granules of a water-soluble sugar.” Id.
`at 24.
`Petitioner relies on Serpelloni for teaching “granules of water-soluble
`
`sugar” that are used to obtain a speckled appearance, wherein “the colored
`particles are constituted essentially of sorbitol.” Id. (quoting Ex. 1006 1:35–
`36) (emphasis omitted). Petitioner contends:
`As . . . explained by Dr. Park, “[i]t would have been readily
`obvious to one of ordinary skill in the art that the speckles
`disclosed by the Prevacid Label could have been comprised of
`the colored granules of a water-soluble sugar such as taught by
`Serpelloni, as Serpelloni specifically teaches colored water-
`soluble sugars imparting a “speckled appearance” (Ex. 1006 col
`1:29-31) to a gum-based composition.” (Ex. 1002, ¶ 24). As
`further explained by Dr. Park, “the Prevacid Label also teaches
`water-soluble sugars as acceptable excipients, the use of a
`colored water-soluble sugar composition would have been
`obvious to one of ordinary skill in the art with a reasonable
`expectation that such would have been successful in producing a
`speckled appearance in a tablet as claimed.” (Id.)
`Pet. 24–25 (alteration in original).
`
`Petitioner argues further that the ordinary artisan would have expected
`that the colored granules of Serpelloni, which were used to achieve a
`speckled appearance in chewing gum, “would have been reasonably
`expected to achieve the same function of imparting a similar speckled
`appearance to tablets such as the tablet disclosed in the Prevacid tablets.” Id.
`at 28 (quoting Ex. 1002 ¶ 24).
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
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`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
`We conclude that Petitioner has shown a reasonable likelihood that it
`would prevail in establishing that independent claim 1 would have been
`obvious over the Prevacid® Label and Serpelloni. In particular, we
`conclude that there is a reasonable likelihood Petitioner would prevail in
`showing that it would have been obvious at the time of invention to use the
`solid particles of Serpelloni, which Serpelloni specifically teaches may be
`used to achieve a speckled appearance, to produce the speckles in the
`speckled orally disintegrating tablets taught by the Prevacid® Label. See,
`e.g., KSR, 550 U.S. at 417 (“[I]f a technique has been used to improve one
`device, and a person of ordinary skill in the art would recognize that it would
`improve similar devices in the same way, using the technique is obvious
`unless its actual application is beyond his or her skill.”). We have carefully
`considered Patent Owner’s arguments to the contrary, but they do not
`convince us otherwise.
`
`Patent Owner argues that the Prevacid® Label does not teach a tablet
`that enables buccal absorption of the active ingredient, as required by “‘an
`orally disintegrating tablet’ consistent with the claim interpretation required
`for the ’170 Patent.” Prelim. Resp. 15. Rather, the tablet taught by
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`Prevacid® Label contains enteric-coated micro-granules of lansoprazole,
`which results in absorption of the active ingredient only after the micro-
`granule leaves the stomach. Id. at 16.
`
`As discussed above, for purposes of this Decision, we have construed
`orally disintegrating tablet as not requiring buccal absorption. Thus, the
`term “orally disintegrating tablet” as used in challenged claim 1
`encompasses the orally disintegrating tablet taught by the Prevacid® Label,
`wherein absorption of the active ingredient occurs after the micro-granule
`leaves the stomach.
`
`Patent Owner argues further that the Prevacid® Label fails to describe
`colored granules as required by the challenged claims. Prelim. Resp. 17.
`Patent Owner argues also that Serpelloni fails to teach “a large multiparticle
`body comprising smaller particles adhered together.” Id. at 23, 30.
`
`Again, as discussed above, we declined to construe “granule” as
`requiring an aggregate of particles. The ’170 patent teaches the use of
`colored granules that “have a particle size from about 10 µm to about 1200
`µm, preferably from about 200 µm to about 800 µm, most preferably from
`about 300 µm to about 500 µm. Ex. 1001, 2:55–58. Serpelloni teaches that
`its particles are “generally from 500 to 1500 µm and more particularly from
`800 to 1200 µm.” Ex. 1006, 1:45–46. The ranges taught by Serpelloni
`overlap with those taught by the ’170 patent, and Serpelloni’s preferred
`range is encompassed by the about 10 µm to about 1200 µm range taught by
`the ’170 patent. Thus, the colored particles taught by Serpelloni appear to be
`encompassed by the term “colored granules” as set forth in challenged claim
`1. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (In cases
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`involving ranges . . . even a slight overlap in range establishes a prima facie
`case of obviousness.”).
`
`Patent Owner argues further as to Serpelloni that its particles are
`encapsulated by a water-insoluble coating, and are intended to be
`masticated. Prelim. Resp. 20. According to Patent Owner, “Serpelloni is
`devoid of any discussion relating to whether the sweetener particles ever
`dissolve, or at what rate,” and the presence of the insoluble coating “is
`tantamount to a ‘teaching away’ from dissolution properties.” Id.
`Specifically Patent Owner contends:
`Combination of the two references as suggested in the
`Petition would require modification of the Prevacid Label
`product to include Serpelloni’s particles insoluble in the oral
`cavity. Thus, the Prevacid Label product could not be ingested,
`especially the particles constituting the active ingredient (the
`Prevacid Label teaches against chewing, so the Serpelloni’s
`particles could never be dissolved and the Prevacid Label
`product would not be ingested in timely fashion). Thus would
`render the Prevacid Label product unsuitable for its intended
`purpose.
`Id. at 32.
`
`Serpelloni teaches the use of colored particles to obtain a speckled
`appearance. Ex. 1006, 1:29–31. We are persuaded that Petitioner provides
`sufficient evidence at this stage to indicate it would have been within the
`level of skill of the ordinary artisan to adapt the particles of Serpelloni to
`provide the speckled appearance for the orally disintegrating tablets taught
`by the Prevacid® Label. See Ex. 10026 ¶ 24; see also In re Keller, 642 F.2d
`
`
`6 Patent Owner argues that the Declaration of Dr. Park is unreliable, and
`should be entitled to no deference. Prelim. Resp. 32–34. The Declarant has
`not been subjected to cross-examination at this point of the proceeding, and
`we decline to discount it for purposes of this Decision. Moreover, we
`
`15
`
`
`
`IPR2016-00245
`Patent 8,440,170 B2
`
`413, 425 (CCPA 1981) (“The test for obviousness is not whether the features
`of a secondary reference may be bodily incorporated into the structure of the
`primary reference; nor is it that the claimed invention must be expressly
`suggested in any one or all of the references. Rather, the test is what the
`combined teachings of the references would have suggested to those of
`ordinary skill in the art”.). Therefore, based on the record before us at this
`time, Petitioner reasonably contends that an ordinary artisan would have had
`reason to use the colored particles disclosed in Serpelloni to create a
`“speckled appearance” (Ex. 1006, 1:29–31), i.e., to create the “orange to
`dark brown speckles” described in the Prevacid® Label (Ex. 1004, 10). Pet.
`23–25 (citing Ex. 1004, 10; Ex. 1006: 1:29–31; Ex. 1002 ¶ 24).
`
`We acknowledge that Serpelloni does not discuss the dissolution rate
`of the sweetener particles. However, like our appellate reviewing court,
`“[w]e will not read into a reference a teaching away from a process where no
`such language exists.” DyStar Textilfarben GmbH & Co. Deutschland KG v.
`C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). Under the proper
`legal standard, a reference will teach away when it suggests that the
`developments flowing from its disclosures are unlikely to produce the
`objective of the invention. Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d
`1371, 1380 (Fed. Cir. 2005). There is no evidence currently of record
`demonstrating that the ordinary artisan would not expect that the particles of
`Serpelloni could be used to produce the speckles in the orally disintegrating
`tablet of the Prevacid® Label.
`
`
`determine that the opinion expressed in paragraph 24 of the Declaration is
`sufficiently supported by the Prevacid Label® and Serpelloni.
`
`16
`
`
`
`IPR2016-00245
`Patent 8,440,170 B2
`
`Patent Owner does not present any arguments specific to dependent
`
`claims 2, 3, 5, 6, 8, and 9. See Prelim. Resp. 34. We have reviewed
`Petitioner’s evidence and claim charts as to the challenge of claims 2, 3, 5, 6,
`8, and 9 over the combination of the Prevacid® Label and Serpelloni, and
`conclude that Petitioner has established a reasonable likelihood that it would
`prevail in showing that those claims also are rendered obvious by those cited
`references.
`For the reasons set forth above, we conclude that Petitioner has
`established a reasonable likelihood that it would prevail in showing that
`claims 1–3, 5, 6, 8, and 9 would have been obvious over the combination of
`the Prevacid® Label and Serpelloni.
`D. Obviousness over the Prevacid® Label (Ex. 1004)
`and Stawski (Ex. 1005)
`Petitioner contends that claims 1–9 are rendered obvious by the
`combination of the Prevacid® Label and Stawski. Pet. 11–23. Patent
`Owner disagrees. Prelim. Resp. 13–19, 21–29.
`
`Petitioner relies on the Prevacid® Label for teaching an orally
`disintegrating tablet that has a speckled appearance. Pet. 13. Petitioner
`notes that the Prevacid® Label teaches that the granules contain mannitol,
`“but does not specifically disclose speckles comprising colored granules of a
`water-soluble sugar.” Id.
`
`Petitioner relies on Stawski for teaching “granules of a water-soluble
`sugar in tablets.” Id. at 14. Petitioner relies on the Declaration of Dr. Park,
`contending that “the ‘blue colored mannitol inclusions’ mentioned in
`Stawski were commercially available at the time of the invention and known
`to be useful as claimed as indicated.” Id. at 15 (quoting Ex. 1002 ¶ 16).
`Petitioner further asserts:
`
`17
`
`
`
`IPR2016-00245
`Patent 8,440,170 B2
`
`
`As further explained by Dr. Park, “as the Prevacid Label also
`teaches water-soluble sugars, including mannitol, as acceptable
`carriers, as well as various dyes, the use of a colored mannitol
`composition would have been obvious to one of ordinary skill in
`the art with a reasonable expectation that such would have been
`successful in producing a speckled appearance in a tablet as
`specifically disclosed by Stawski.”
`Id. at 16 (quoting Ex. 1002 ¶ 17).
`
`Patent Owner contends that the inclusions of Stawski are meant to
`survive disintegration of the tablet. Prelim. Resp. 18. In particular, Patent
`Owner argues that “the inclusions disclosed in Stawski are abrasive, and
`dissolve less rapidly than the surrounding matrix. This is directly contrary to
`the requirement in the ‘170 patent that its ‘colored granules’ dissolve at least
`as fast as the rest of the ODT.” Id. at 19.
`
`A determination of unpatentability on the ground of obviousness must
`include “articulated reasoning with some rational underpinning to support
`the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed.
`Cir. 2006). The obviousness analysis “should be made explicit” and it “can
`be important to identify a reason that would have prompted a person of
`ordinary skill in the relevant field to combine the elements in the way the
`claimed new invention does.” KSR, 550 U.S. at 418. We agree with Patent
`Owner that Petitioner has not sufficiently articulated reasoning, with
`adequate rational underpinning, in relation to the ground that challenged
`claim 1 is rendered obvious by the combination of the Prevacid® Label and
`Stawski.
`
`As noted above, Stawski teaches that its “inclusions” (i.e., particles)
`are abrasive, and dissolve more slowly than the remainder of the matrix. Ex.
`1005 ¶¶ 52–54. Stawski further teaches that its abrasive particles provide an
`abrasive surface to the product so that the “abrasive surface is suitable for
`
`18
`
`
`
`IPR2016-00245
`Patent 8,440,170 B2
`
`scrubbing the top surface of the tongue within the oral cavity.” Id. at ¶ 53.
`Petitioner has failed to provide a reason, with adequate rational
`underpinning, as to why the ordinary artisan would have used those abrasive
`inclusions as speckles in the orally disintegrating tablet of the Prevacid®
`Label.
`
`III. CONCLUSION
`For the foregoing reasons, we are persuaded that the Petition
`establishes a reasonable likelihood that Petitioner would prevail in showing
`claims 1–3, 5, 6, 8, and 9 of the ’170 patent are unpatentable under 35
`U.S.C. §103(a).
`
`At this stage of the proceeding, the Board has n
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