`Trials@uspto.gov
`Entered: November 30, 2017
`Tel: 571-272-7822
`
`
`
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ROQUETTE FRERES, S.A.,
`Petitioner,
`
`v.
`
`TATE & LYLE INGREDIENTS AMERICAS LLC,
`Patent Owner.
`____________
`
`Case IPR2017-01507
`Patent 8,057,840 B2
`____________
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314; 37 C.F.R. § 42.108
`
`
`
`Before LORA M. GREEN, GRACE KARAFFA OBERMANN,
`and JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`
`
`
`
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`Case IPR2017-01507
`Patent 8,057,840 B2
`
`
`I. INTRODUCTION
`Petitioner filed a Petition for inter partes review of claims 1–51 of
`U.S. Patent No. 8,057,840 B2 (Ex. 1001, “the ’840 patent”). Paper 1
`(“Pet.”). Patent Owner filed a Preliminary Response. Paper 10 (“Prelim.
`Resp.”). With Board preauthorization (Paper 14), Petitioner filed a Reply
`(Paper 15) and Patent Owner filed a Sur-Reply (Paper 18). Based on the
`information presented, we hold that Petitioner has not demonstrated a
`reasonable likelihood of prevailing at trial in showing that at least one
`challenged claim of the ’840 patent is unpatentable.
`Accordingly, we deny the Petition.
`A. Related Proceedings
`Petitioner submits that there are no related proceedings. Pet. 1.
`Petitioner states that it filed, concurrently with the instant Petition, a petition
`for inter partes review of a related patent, U.S. Patent No. 7, 608,436 B2.
`Id.; see Case IPR2017-01506 (“IPR1506”). Concurrently herewith, we issue
`a decision in IPR1506.
`
`B. The ’840 Patent (Ex. 1001)
`The ’840 patent is entitled “Food Products Comprising a Slowly
`Digestible or Digestion Resistant Carbohydrate Composition.” Ex. 1001,
`Title. The specification discloses “a need for edible materials which have a
`reduced content of easily digestible carbohydrates, and which can be used in
`place of, or in addition to, conventional carbohydrate products in foods,”
`such as candy, breakfast cereal, yogurt, ice cream, and marshmallows.
`Ex. 1001, 1:22–25, 3:23–27, 28:59–29:2 (Example 13), 32:18–62
`(Example 17), 32:64–33:17 (Example 18), 34:13–33 (Example 21), 34:38–
`62 (Example 22).
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`The specification further discloses a food product that comprises an
`oligosaccharide composition, which may be produced from a feed
`composition that includes, for example, monosaccharides, linear
`oligosaccharides, or a mixture of both. Id. at 4:38–41. Suitable starting
`materials for the feed composition include dextrose syrups, corn syrup, and
`maltodextrose solutions. Id. at 4: 57–62. The feed composition may be
`subjected to a heating step and a contacting step. Id. at 5:21–29, 6:24–32,
`49:20–37 (claim 1). During the contacting step, the feed composition may
`be contacted with a catalyst, such as an enzyme or acid, for a period of time
`sufficient to accelerate the rate of cleavage or formation of glucosyl bonds to
`cause formation of non-linear oligosaccharides. Id. at 5:3–6:17. The
`product materials may be tested for digestion resistance using a technique
`known as the Englyst assay. Id. at 1:37–62 (summary of the invention),
`28:23–57 (Example 12).
`The food product of the claimed invention has a higher concentration
`of non-linear oligosaccharides than linear oligosaccharides. Id. at 5:3–9, 40–
`41, 49:20–37 (claim 1, specifying a food product comprising an
`“oligosaccharide composition” that “contains a higher concentration of non-
`linear saccharide oligomers than linear saccharide oligomers”). On that
`point, the specification discloses that “[g]astrointestinal enzymes readily
`recognize and digest carbohydrates in which the dextrose units are linked
`alpha (1→4) (‘linear’ linkages)” and, further, that “[r]eplacing these linkages
`with alternative linkages (alpha (1→3), alpha (1→6) (‘non-linear’ linkages)
`or beta linkages, for example) greatly reduces the ability of gastrointestinal
`enzymes to digest the carbohydrate.” Id. at 5:47–54. The specification
`further defines the claim terms “slowly digestible,” “digestion-resistant,”
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`and “primarily digestion-resistant” in a disclosure that we discuss in our
`analysis of the patentability challenges. Id. at 1:37–62. Where a distinction
`is not necessary to our analysis, we refer to these limitations collectively as
`“the digestibility limitations” of the claims.
`C. Illustrative Claim
`Claims 1 and 44 are the only independent claims. Claim 1 is
`reproduced below:
`1. A food product that comprises an oligosaccharide composition that
`is digestion resistant or slowly digestible and that is made by a process
`comprising:
`
`heating an aqueous feed composition that comprises at least one
`monosaccharide or linear saccharide oligomer, and that has a solids
`concentration of at least about 70% by weight, to a temperature of at
`least about 40º C.; and
`contacting the feed composition with at least one catalyst that
`accelerates the rate of cleavage or formation of glucosyl bonds for a
`time sufficient to cause formation of non-linear saccharide oligomers,
`wherein the oligosaccharide composition contains a higher
`concentration of non-linear saccharide oligomers than linear
`saccharide oligomers, and comprises non-linear saccharide oligomers
`having a degree of polymerization of at least three in a concentration
`of at least about 20% by weight on a dry solids basis.
`Ex. 1001, 49:21–37.
`Claim 44 specifies “[a] food product comprising a carbohydrate
`composition that is primarily slowly digestible or digestion resistant” and
`limits the concentration of non-linear and linear saccharide oligomers, but
`does not recite a heating or contacting process step. Id. at 52:7–16.
`D. The Asserted Evidence
`The Petition asserts the following prior art references in the grounds
`
`of unpatentability:
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`(1) WO 98/41545 patent application to Pankaj Shah et al., published
`
`September 24, 1998 (Ex. 1004, “Shah”);
`
`(2) S.A.S. Craig et al., Polydextrose as Soluble Fiber and
`Complex Carbohydrate, in Complex Carbohydrates in Foods 229–247
`(Susan Sungsoo Cho et al. eds. 1999) (Ex. 1005, “Craig”);
`
`(3) US Pat. No. 5,424,418, issued to Pierrick Duflot on June 13, 1995
`(Ex. 1006, “Duflot”);
`
`(4) US Pat. No. 3,876,794, issued to Hans H. Rennhard on April 8,
`1975 (Ex. 1007, “Rennhard”);
`
`(5) Robert P. Allingham, Polydextrose - A New Food Ingredient:
`Technical Aspects, in Chemistry of Foods and Beverages: Recent
`Developments 293–303 (George Charalambous & George Inglett eds. 1982)
`(Ex. 1008, “Allingham);
`
`(6) R. E. Smiles, The Functional Applications Of Polydextrose, in
`Chemistry of Foods and Beverages: Recent Developments 305–322
`(George Charalambous & George Inglett eds. 1982) (Ex. 1009, “Smiles”);
`
`(7) US Pat. No. 4,518,581, issued to Toshio Miyake et al. on May 21,
`1985 (Ex. 1010, “Miyake”);
`
`(8) US Pat. No. 4,782,045, issued to Yoshiaki Machida et al. on
`November 1, 1988 (Ex. 1011, “Machida”).
`
`The Petition is supported by a declaration of Dr. Alexei Demchenko.
`Ex. 1002. The Reply is supported by a supplemental declaration of
`Dr. Demchenko. Ex. 1050. The Sur-Reply is supported by a declaration of
`Dr. Robert Linhardt. Ex. 2001.
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`E. The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–51 of the ’840
`patent on the following grounds (Pet. 5):
`
`Claims
`
`1–48, 50, and 51
`1–48, 50, and 51
`1–48,50, and 51
`1–48, 50, and 51
`1–48, 50, and 51
`1–48, 50, and 51
`1–48, 50, and 51
`44 and 49
`
`
`Basis
`
`§ 102(b)
`§ 103
`§ 102(b)
`§ 103
`§ 102(b)
`§ 103
`§ 102(b)
`§ 102(b)
`
`References
`
`Shah
`Shah and Craig1
`Duflot
`Duflot and Rennhard
`Allingham and Smiles2
`Allingham and Smiles
`Miyake
`Machida
`
`II. ANALYSIS
`A. Level of Ordinary Skill in the Art
`We consider the grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of the
`
`
`1 The Petition identifies “a POSA’s knowledge” as prior art evidence in the
`grounds based on obviousness. Pet. 5. We consider evidence, reflecting the
`background knowledge of a person of ordinary skill in the art, to the extent
`that it is identified and analyzed in the briefs.
`
` Petitioner argues that Allingham and Smiles “were published together back
`to back” and describe “complementary aspects of a single embodiment.”
`Pet. 55. Thus, in Petitioner’s view, these “should be considered a single
`reference for the purposes of anticipation.” Id. at 55–56 (citation omitted).
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`invention. Petitioner argues that an ordinary artisan would typically have
`had at least a Master’s Degree in the chemical arts and two or three years of
`experience in carbohydrate synthesis, analysis, or process development.
`Pet. 6. Petitioner’s definition, which is not challenged in the Preliminary
`Response, is comparable to the level of skill reflected in the asserted prior
`art. For purposes of this decision, we find that the prior art itself is sufficient
`to demonstrate the level of ordinary skill in the art at the time of the
`invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)
`(the prior art itself can reflect appropriate level of ordinary skill in the art).
`
`B. Claim Construction
`The Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`(2016). Under that standard, claim terms are given their ordinary and
`customary meaning in view of the specification, as understood by a person
`of ordinary skill in the art at the time of the invention. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`No claim term requires express construction for purposes of this
`decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd.,
`868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that
`are in controversy, and only to the extent necessary to resolve the
`controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999))). However, the digestibility limitations require
`discussion, which we provide below.
`
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`C. Adequacy of Proof Regarding the Digestibility Limitations
`A dispositive question arises whether the Petition identifies evidence
`adequate to prove that the asserted prior art discloses or suggests a food
`product comprising an oligosaccharide composition that exhibits the degree
`of human digestibility required by the challenged claims. Compare Pet. 25–
`28 with Prelim. Resp. 2, 14–23. That property is variously specified as
`“digestion resistant,” “slowly digestible,” or “primarily slowly digestible” in
`the challenged claims. Ex. 1001, 49:22–23 (claim 1), 52:7–16 (claim 44).
`We organize our discussion into three subparts: (1) the parties’ opposing
`views on the quality of proof required; (2) an analysis of the Petition
`evidence; and (3) our findings on the adequacy of the Petition evidence.
`(1) The Dispute Surrounding the Quality of Proof Required
`The oligosaccharide composition of the claimed food product must
`exhibit a specified degree of human digestibility (“slowly digestible,”
`“digestion resistant,” or “primarily digestion resistant”). Ex. 1001, 49:22–23
`(claim 1), 52:7–16 (claim 44). The specification provides guidance on how
`one may assess whether a given oligosaccharide composition meets the
`digestibility limitations:
`“Slowly digestible” as the term is used herein means that a substantial
`quantity (e.g., at least about 50% on a dry solids basis, and in some
`cases at least about 75%, or at least about 90%) of the carbohydrate
`present in the stream are either not digested at all in the human stomach
`and small intestine, or are only digested to a limited extent. In another
`embodiment of the invention, the oligosaccharide-rich stream is
`resistant to digestion by the human digestive system.
`Both in vitro and in vivo tests can be performed to estimate rate
`and extent of carbohydrate digestion in humans. The “Englyst Assay”
`is an in vitro enzyme test that can be used to estimate the amounts of a
`carbohydrate ingredient that are rapidly digested, slowly digestible or
`resistant to digestion (European Journal of Clinical Nutrition (1992)
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`Volume 46 (Suppl. 2), pages S33–S50). Thus, any reference herein to
`“at least about 50% by weight on a dry solids basis” of a material being
`slowly digestible, or to a material being “primarily slowly digestible,”
`means that the sum of the percentages that are classified as slowly
`digestible or as resistant by the Englyst assay totals at least about 50%.
`Likewise, any reference herein to “at least about 50% by weight on a
`dry solids basis” of a material being digestion-resistant, or to a material
`being “primarily digestion resistant,” means that the percentage that is
`classified as resistant by the Englyst assay is at least about 50%.
`Ex. 1001, 1:38–62.
`
`The parties differ in their interpretation of that disclosure. As an
`initial matter, we agree with Petitioner that the quality of proof required to
`establish the requisite degree of digestibility “is a separate question” from
`the broadest reasonable interpretation of the claim terms. Pet. 26.
`In Petitioner’s view, the above-quoted disclosure supports a finding
`that the Englyst assay is “one possible proxy for what happens in a human
`digestive tract” and that “one may prove” that a composition meets the
`digestibility limitations through other methods of “in vitro testing, in vivo
`testing, and . . . structural analysis.” Pet. 25–26. Patent Owner disagrees,
`arguing that the quoted disclosure makes plain that the Englyst assay “must
`be used to determine” whether an oligosaccharide composition meets the
`digestibility limitations of the challenged claims. Prelim. Resp. 15.
`For reasons that follow, we accept for the purposes of this decision
`Petitioner’s view that the specification does not identify the Englyst assay as
`the sole or exclusive means for determining whether an oligosaccharide
`composition exhibits the claimed property (a degree of human digestibility).
`We nonetheless determine that the Petition fails to advance evidence
`sufficient to prove that any prior art sample composition would have
`exhibited that claimed property.
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`(2) Analysis of the Petition Evidence
`The Petition does not direct us to an Englyst assay or any other in
`vitro or in vivo test results to establish that a prior art sample composition
`meets or suggests the digestibility limitations of the challenged claims.
`Pet. 33–76; Prelim. Resp. 18. Instead, the Petition directs us to
`Dr. Demchenko’s opinion that “the Englyst assay would confirm” that
`samples obtained from the prior art are “digestion resistant (and therefore
`also slowly digestible).” Prelim. Resp. 22 (quoting Pet. 36, 47, 59, 70).
`The Petition does not articulate a persuasive reason why
`Dr. Demchenko’s opinion, regarding what the Englyst assay “would
`confirm,” is an adequate evidentiary substitute for in vitro or in vivo testing
`to establish the degree of digestibility required by the claims. On that point,
`the specification is instructive on the quality of proof required. Ex. 1001,
`1:38–62 (disclosing that “[b]oth in vitro and in vivo tests can be performed
`to estimate the rate and extent of carbohydrate digestion in humans”),
`28:23–57 (Example 12, entitled “Englyst Digestion Assay,” disclosing
`conditions and results of testing for digestibility of sample compositions
`obtained from other examples disclosed in the specification—namely,
`Examples 7, 8, and 10).
`On this record, and in the context of the specification disclosures
`relating to how one may assess human digestibility in this particular field of
`endeavor, we find that the Petition does not show sufficiently that opinion
`testimony—directed to the expected outcome of an Englyst assay—is
`sufficient to establish the requisite degree of human digestibility that would
`be exhibited by an oligosaccharide composition—which, according to
`the ’840 patent specification, is produced from complex polymerization
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`reactions carried out on carbohydrates by application of heat and exposure to
`catalysts, including hydrochloric acid or glucoamylase. Pet. 36, 47, 59, 70;
`Ex. 1001, 5:10–39, 22:25–33 (Example 5), 24:50–25:21 (Example 7),
`25:23–59 (Example 8), 26:30–27:4 (Example 10).
`The Petition also advances a “structural analysis” as confirmation that
`prior art samples comprise oligosaccharides that exhibit the property (a
`degree of digestibility) required by each challenged claim. Pet. 36. For the
`grounds based on Shah, the Petition discusses structural aspects of pure or
`commercial forms of polydextrose. Pet. 35–37. The Petition does not
`clearly articulate how that information demonstrates that the polymerization
`reaction products of Shah’s process would exhibit the property (a degree of
`digestibility) required by the claims. On that point, the Petition directs us to
`Craig for disclosure that may bear on the linearity of polydextrose in
`isolation, but fails to explain adequately how Craig’s disclosure establishes
`the degree of digestibility exhibited by the polymerization products obtained
`from Shah’s Example 10, involving “Polymerization of Liquid Starting
`Materials with Various Levels of Phosphoric Acid Catalyst,” or Example 11,
`involving “Polymerization of Liquid Starting Materials with Citric Acid Plus
`Various Levels of Hydrochloric Acid,” upon which the Petition relies to
`make out the challenge. Ex. 1004, 21:30–31, 22:29–30; Pet. 33–35.
`Similarly, Petitioner identifies textbooks (Allingham and Smiles) that
`discuss structural aspects of polydextrose in the abstract, but does not
`adequately tie that disclosure to any prior art sample composition, much less
`“[a] food product” comprising “an oligosaccharide composition that is
`digestion resistant or slowly digestible” or “primarily slowly digestible” in a
`human digestive tract as required by each independent challenged claim.
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`Ex. 1001, 49:21–22 (claim 1), 52:5–6 (claim 44); see Pet. 58–59 (failing to
`make out that connection).
`The Petition purports to rely on a structural analysis of reaction
`products identified in Duflot, Miyake, and Machida, but falls short of
`establishing adequately that those references disclose or suggest a sample
`composition that meets the digestibility limitations. Pet. 46–48 (Duflot),
`69–70 (Miyake), 75–76 (Machida). The Petition relies on Dr. Demchenko’s
`opinion regarding “the expected result” of Product D of Duflot’s Example 3.
`Pet. 47 (citing Ex. 1002 ¶ 235). But Duflot describes a two-catalyst process
`for preparing glucose polymers, without disclosing the degree to which its
`reaction product is digestible, or the relative concentrations of linear and
`non-linear oligosaccharides present in the reaction product. Ex. 1006, 13:1–
`58. Here again, in light of the specific facts presented in this case and the
`particular field of endeavor at issue, we are not persuaded that
`Dr. Demchenko’s opinion on the “expected result” of this complex
`polymerization reaction is sufficient to make out the claimed property (a
`degree of digestibility). See ibid. (Dr. Demchenko’s opinion).
`The Petition also directs us to Miyake’s Example 4 reaction product.
`Pet. 69. That reaction product is formed by a process of treating a dextran
`with sulfuric acid. Ex. 1010, 9:35–10:17. Like Duflot, Miyake does not
`disclose the degree of digestibility that characterizes the reaction product.
`Id. Nor does the reference describe the relative concentrations of linear and
`non-linear oligosaccharides present in the product. Id. The Petition
`advances Dr. Demchenko’s opinion that “the Englyst assay would confirm
`that the Miyake product is digestion resistant (and therefore also slowly
`digestible).” Pet. 70 (citing Ex. 1002 ¶ 470 (opining about the “expected
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`behavior” of Miyake’s Example 4 reaction product)). Given that Miyake’s
`reaction product is the result of a complex polymerization reaction, we find
`that Dr. Demchenko’s opinion on the “expected behavior” of Miyake’s
`Example 4 composition is insufficient to make out the claimed property.
`The Petition draws additional structural conclusions about a reaction
`product that is synthesized in Machida from a starting syrup formed by
`reacting a sugar transfer enzyme with a starch that has been hydrolyzed by
`debranching enzyme and α-amylase. Pet. 75–76. Machida does not disclose
`the degree to which the reaction product is digestible or information relating
`to the relative concentrations of linear and non-linear oligosaccharides
`present in the reaction product. Ex. 1011, 2:14–65. And the Petition does
`not adequately explain how or why Machida’s reaction product necessarily
`exhibits “a greater concentration of non-linear than linear oligosaccharides.”
`Pet. 75–76 (citing, but not adequately discussing, Ex. 1002, ¶¶ 576–578).
`Patent Owner, for its part, responds that “hand-waving regarding
`structural analysis, even by an ‘expert,’ is not a proper way to determine
`digestibility according to the ’840 Patent specification.” Prelim. Resp. 23.
`(3) Findings on the Adequacy of the Petition Evidence
`Our findings on the adequacy of the Petition evidence are informed by
`
`the field of invention (carbohydrate polymerization chemistry) and the
`quality of proof (“in vitro and in vivo tests”) that are discussed in the
`disclosure of the ’840 patent. Ex. 1001, Abstract, 1:46–47, 28:23–57
`(Example 12). We find that the Petition does not demonstrate sufficiently
`the degree of human digestibility exhibited by any prior art sample
`composition, given the lack of information pertaining to any in vitro or in
`vivo test results, and the lack of information sufficient to show persuasively
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`a connection between the structure of any prior art sample composition and
`the specified degree of human digestibility.
`Even if we accept Petitioner’s view that the Englyst assay “reflects
`only one non-exclusive means of proving whether a sample composition”
`meets the specified degree of digestibility, we find that the Petition advances
`proof inadequate to demonstrate a reasonable likelihood that the claimed
`property is met by any prior art sample composition. Pet. 26. On that point,
`the Petition depends on Dr. Demchenko’s opinions about the “expected
`behavior” of feed compositions that are subjected to complex polymerization
`conditions, as well as “insights with respect to predicting the effect of the
`human digestion system.” Ex. 1002 ¶¶ 136, 138, 237, 275, 347, 390. Based
`on the particular facts and circumstances of this case, we find that
`Dr. Demchenko’s opinions, directed to “expected behaviors” and predictive
`“insights” (id.), are insufficient to show a reasonable likelihood that a prior
`art composition meets or suggests the degree of digestibility specified in the
`challenged claims.
`We agree with Patent Owner that the “structural analysis” set forth in
`the Petition depends on “conclusory statements made by Dr. Demchenko
`that” certain prior art reaction products “would all be slowly digestible” in a
`human digestive tract. Prelim. Resp. 18. The Petition identifies no “in vitro
`testing” or “in vivo testing” tending to confirm Dr. Demchenko’s opinions.
`Pet. 36. And the “structural analysis” advanced in the Petition is not
`adequately explained or tethered to any particular prior art food product or
`sample composition. Id. at 35–37 (Shah), 46–47 (Duflot), 58–59
`(Allingham/Smiles), 69–70 (Miyake), 76 (Machida); see 37 C.F.R.
`§ 42.22(a)(2) (petition must contain a “full statement of the reasons for the
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`relief requested, including a detailed explanation of the significance of the
`evidence”).
`In order to prevail here, Petitioner must direct us to evidence adequate
`to demonstrate a reasonable likelihood that the claimed property (a degree of
`digestibility) is disclosed in, or suggested by, a prior art composition. For
`the reasons set forth above, Petitioner has failed to do so.
`Accordingly, we deny the Petition as Petitioner has failed to direct us
`to evidence sufficient to demonstrate a reasonable likelihood that the
`asserted prior art references disclose or suggest a sample composition that
`meets the digestibility limitations of the challenged claims.
`
`III. CONCLUSION
`On this record, we hold that Petitioner has not demonstrated a
`reasonable likelihood of prevailing at trial in showing that at least one
`challenged claim of the ’840 patent is unpatentable.
`
`IV. ORDER
`
`It is
`ORDERED that the Petition is denied and no trial is instituted.
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`PETITIONER:
`David L. Glandorf
`Joseph Evall
`Daniel J. Thomasch
`GIBSON, DUNN & CRUTCHER LLP
`dglandorf@gibsondunn.com
`jevall@gibsondunn.com
`dthomasch@gibsondunn.com
`
`
`PATENT OWNER:
`Paul H. Berghoff
`James V. Suggs
`S. Richard Carden
`McDONNELL BOEHNEN HULBERT & BERGHOFF LLP
`Berghoff@mbhb.com
`Suggs@mbhb.com
`Carden@mbhb.com
`
`
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