Trials@uspto.gov
`571.272.7822
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` Paper No. 9
` Entered: January 18, 2018
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`EBORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ELYSIUM HEALTH INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
`
`Case No. IPR2017-01796
`Patent 8,197,807 B2
`____________
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`THORNE - EXHIBIT 1027
`
`
`571.272.7822
`
` Paper No. 9
` Entered: January 18, 2018
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`EBORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ELYSIUM HEALTH INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
`
`Case No. IPR2017-01796
`Patent 8,197,807 B2
`____________
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`THORNE - EXHIBIT 1027
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`IPR2017-01796
`Patent 8,197,807 B2
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`I.
`A. Background
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`INTRODUCTION
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`Elysium Health Inc., (“Petitioner”) filed a Petition requesting inter
`partes review of claims 1–3 of U.S. Patent No. 8,197,807 B2 (“the ‘’807
`patent”). Paper 1 (“Pet.”). The Trustee of Dartmouth University (“Patent
`Owner”) filed a Preliminary Response contending that the Petition should be
`denied as to all the challenged claims. Paper 8 (“Prelim. Resp.”).
`We have authority under 37 C.F.R. § 42(a) and 35 U.S.C. § 314,
`which provides that an inter partes review may not be instituted unless the
`information presented in the Petition “shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Having considered
`the arguments and the evidence presented, for the reasons described below,
`we determine that Petitioner has not demonstrated that there is a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged by the Petition. Accordingly, we decline to institute an inter
`partes review.
`B. Additional Proceedings
`
`Petitioner represents that the ’807 patent is at issue in
`ChromaDex, Inc., v Elysium Health, Inc., Case No. 16-cv-02277-KES
`(C.D.Cal.). Pet. 29. Petitioner also represents that a petition for inter partes
`review has been filed challenging related U.S. Patent No. 8,383,086, which
`is now IPR 2017-001795. Id. at 29–30.
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`C. The ’807 Patent (Ex 1001)
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`The ’807 patent, titled “Nicotinamide Riboside Kinase Compositions
`and Methods for Using the Same” purports to disclose a dietary supplement
`composition containing nicotinamide riboside wherein the nicotinamide
`riboside is obtained from a natural or synthetic source. Ex. 1001, col. 4, ll.
`8–23.
`
`D. Illustrative Claim
`
`Of the challenged claims, claim 1 is independent. Claims 2 and 3
`depend from claim 1. Claim 1 is illustrative of the claimed subject matter
`and reads as follows:
`1. A composition comprising isolated nicotinamide riboside in
`combination with one or more of tryptophan, nicotinic acid,
`or nicotinamide, wherein said combination is in admixture
`with a carrier comprising a sugar, starch, cellulose, powdered
`tragacanth, malt, gelatin, talc, cocoa butter, suppository wax,
`oil, glycol, polyol, ester, agar, buffering agent, alginic acid,
`isotonic saline, Ringer’s solution, ethyl alcohol, polyester,
`polycarbonate, or polyanhydride, wherein said composition is
`formulated for oral administration and increases NAD+
`biosynthesis upon oral administration.
`Ex. 1001 col. 53, l. 59–col. 54, l. 59.
`
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`E. The Alleged Grounds of Unpatentability
`
`Petitioner contends that the challenged claims are unpatentable on the
`following grounds1:
`
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`1 Petitioner supports its challenge with the Declaration of Joseph A. Baur,
`Ph.D. Ex 1002 (“Baur Decl.”).
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`3
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`Basis
`§ 102
`§ 102
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`CLAIM CONSTRUCTION
`II.
`A. Legal Standard
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`IPR2017-01796
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`References
`Goldberger et al.2
`Goldberger and Tanner3
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`Claims Challenged
`1–3
`1–3
`
`“A claim in an unexpired patent that will not expire before a final
`written decision is issued shall be given its broadest reasonable construction
`in light of the specification of the patent in which it appears.” 37 C.F.R.
`§ 42.100(b). When applying that standard, we interpret the claim language
`as it should be understood by one of ordinary skill in the art in light of the
`specification. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir.
`2010). Under that standard, the claim terms are generally given their
`ordinary and customary meaning as would be understood by one of ordinary
`skill in the art in the context of the entire disclosure. See In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (“The ordinary and
`customary meaning ‘is the meaning that the term would have to a person of
`ordinary skill in the art in question.’”). Only terms which are in controversy
`need to be construed and only then to the extent necessary to resolve the
`
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`2 Goldberger et al., A Study of the Blacktongue-Preventative Action of 16
`Foodstuffs, With Special Reference to the Identity of Blacktongue of Dogs
`and Pellagra of Man, 43 Pub. Heath Reports 1385 (1928) (“Goldberger et
`al.”). Ex. 1005.
`3 Goldberger and Tanner, A Study of the Treatment and Prevention of
`Pellagra, 39 Pub. Health Reports 87 (1924) (“Goldberger and Tanner”), Ex.
`1006.
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`controvery, Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999).
`B. Isolated
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`Claim 1 recites a composition comprising “isolated nicotinamide
`riboside.” Ex. 1001, col. 53, l. 59. Claim 2 state that the nicotinamide
`riboside “is isolated from a natural or synthetic source.” Id. at col. 54, ll.
`60–61.
`Petitioner contends that the term “isolated” should be interpreted to
`mean “separated or substantially free from at least some of the other
`components of the naturally occurring organism.” Pet. 6. Similarly,
`Petitioner contends that the phrase “is isolated” in claim 2 should be
`construed to mean “is separated from at least some of the other components
`of the naturally occurring organism.” Id. at 7.
`In support of its proposed constructions, Petitioner cites in part to the
`following teaching in the Specification:
` The present invention is an isolated nucleic acid containing a
`eukaryotic nucleotide sequence encoding a nicotinamide
`riboside kinase polypeptide. As used herein, an isolated
`molecule (e.g., an isolated nucleic acid such as genomic DNA,
`RNA or cDNA or an isolated polypeptide) means a molecule
`separated or substantially free from at least some of the other
`components of the naturally occurring organism, such as for
`example, the cell structural components or other polypeptides
`or nucleic acids commonly found associated with the molecule.
`When the isolated molecule is a polypeptide, said peptides is at
`least about 25%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%,
`97%, 98%, 99% or more pure (w/w).
`
`Ex. 1001, col. 9. ll. 21–32; Pet. 6.
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`Patent Owner contends that the term “isolated” should be construed to
`mean substantially free from other molecules. Prelim. Resp. 7. Patent
`owner contends that the term “is isolated” as used in claim 2 should be
`construed to mean “fractionated from other molecular components.” Id.
`In support of its contention regarding the term “isolated” as used in
`claim 1, Patent Owner relies upon the same passage in the Specification
`cited above. Id. at 8. Patent Owner also emphasizes the Specification’s
`teaching that the nicotinamide riboside “can be from a natural or synthetic
`source identified by the method of the instant invention, or can be
`chemically synthesized using established methods.” Id. at 9 (citing
`Ex. 1001, col. 28 ll. 58–63). Patent Owner argues that “the claims do not
`cover natural sources of nicotinamide riboside,” but “[i]nstead, the patent
`specification identifies various natural and synthetic sources for the
`compound and then teaches a person of ordinary skill in the art how to
`isolate nicotinamide riboside from those sources, including from cow’s
`milk.” Id. at 11 (emphasis added). Patent Owner also contends that its
`proposed construction is consistent with the language of the claims insofar
`as independent claim 1 refers to the isolated nicotinamide riboside molecule
`itself (which may be chemically synthesized), while dependent claim 2 is
`narrower and “further specifies that nicotinamide riboside ‘is isolated from a
`natural or synthetic source,’ to the exclusion of chemically synthesizing the
`compound.” Id. at 12–13. Patent Owner argues that Petitioner’s proposed
`constructions are inconsistent with the Specification and claims and are
`unreasonably broad insofar as they encompasses cow’s milk as the claimed
`composition whereas the Specification only identifies cow’s milk as a
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`natural source from which nicotinamide riboside may be isolated. Id. at 14–
`18.
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`The term “isolated” as defined and used in the Specification embraces
`compositions containing nicotinamide riboside in which only some of the
`other naturally occurring components associated with the nicotinamide
`riboside have been removed. Ex. 1001, col. 9, ll. 23–26. Nonetheless, the
`question that remains is how much of those other components must be
`removed to meet the “isolated” claim limitations. In other words, how pure
`must the nicotinamide riboside be in order for it to be considered “isolated”?
`The Specification provides guidance concerning the required purity of
`an “isolated molecule” in the paragraph recited above indicating that an
`isolated polypeptide is at least about 25% pure (w/w). Ex. 1001, col. 9, ll.
`31–33. We recognize that the claims of the ’807 patent refer to “isolated
`nicotinamide riboside” and not “isolated nicotinamide riboside kinase,” the
`polypeptide to which the Specification refers in describing the meaning of an
`“isolated molecule” as set forth above. Compare id. at col. 53, ll. 59–60,
`with id. at 9:21–33. Although the Specification only refers to the purity of
`polypeptides, we find that, when read in the broader context of the entire
`patent, the person of ordinary skill in the art would also understand that a
`minimal level of purity would also be required for other types of “isolated”
`molecules, including specifically nicotinamide riboside. We find that it
`would be unreasonable under the broadest reasonable interpretation standard
`to construe “isolated” to only require separation from “some”—no matter
`how insignificant—amount of other components of the natural source of
`nicotinamide riboside (e.g., cow’s milk). We find that in light of the
`Specification, “some amount” requires a measure, which is not answered by
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`Patent Owner’s assertion that “isolated” means “substantially free from other
`molecules.”
`Thus, based on our consideration of the claim language, the
`Specification, and the parties’ arguments, we determine that the broadest
`reasonable interpretation of the term “isolated” requires that the
`nicotinamide riboside is separated or substantially free from at least some of
`the other components associated with the source of the molecule such that it
`constitutes at least 25% (w/w) of the composition.
`ANALYSIS
`Petitioner contends that claims 1–3 are anticipated by Goldberger et
`al. and by Goldberger and Tanner. Pet. 5. As discussed more fully below
`we conclude that, on the record before us, Petitioner has not demonstrated
`that there is a reasonable likelihood that it will prevail on either ground.
`A. Anticipation by Goldberger et al.
`
`Goldberger et al. discloses a study of foodstuffs for the prevention of
`blacktongue in dogs. Ex. 1005, 1385. Blacktongue is a canine condition
`similar to pellagra in humans. Id. at 1385–86. Like pellagra, blacktongue is
`caused by a deficiency of NAD+. Ex. 1010, 2. In the study, dogs were fed a
`pellagra producing diet along with several candidates for preventing
`pellagra. Ex. 1005, 1387–88. Among the candidates evaluated by
`Goldberger et al. was milk, including skim milk. Id. at 1402–05.
`Goldberger et al. concluded that skim milk exercised a blacktongue
`preventative action. Id. at 1404.
` “Under 35 U.S.C. § 102, every limitation of a claim must identically
`appear in a single prior art reference for it to anticipate the claim.” Gechter
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`v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “A single prior art
`reference may anticipate without disclosing a feature of the claimed
`invention if such feature is necessarily present, or inherent, in that
`reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958(Fed. Cir. 2014)
`citing Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir.
`2003)).
`Petitioner argues that all of the limitations of claims 1–3 are disclosed
`by Goldberger et al. Pet. 7–16. Specifically, Petition asserts that “[t]he milk
`disclosed in Goldberger et al. inherently comprises a composition
`comprising isolated nicotinamide riboside in combination with tryptophan
`and nicotinamide” as shown by Trammell I. 4 Pet. 13 (citing Ex. 1002 (Baur
`Decl.) ¶¶ 11, 31). Petitioner further asserts that the nicotinamide riboside in
`the Goldberger et al.’s skim milk is “isolated” because it is removed from
`the cow and further isolated during the process of converting the whole milk
`from the cow to skim milk by removing fat. Id. at 12 (citing Ex. 1002 ¶ 30).
`We are not persuaded that Petitioner has shown sufficiently, on the
`present record and for purposes of the present decision, that Goldberger et
`al. discloses all of the limitations of claims 1–3.
`Claim 1 is directed to a composition comprising isolated nicotinamide
`riboside. Ex. 1001, col. 53, ll. 59–60. The nicotinamide is in combination
`with one or more of tryptophan, nicotinic acid, or nicotinamide. Id. at col.
`53, ll. 60–61. The combination is in an admixture of a carrier which may
`comprise a sugar. Id. at col. 53, l. 62. The composition is formulated for
`
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`4 Trammell et al., “Nicotinamide Riboside Is a Major NAD+ Precursor
`Vitamin in Cow Milk,” 146 J. Nutrit. 965 (2016). (“Trammell I) Ex. 1007.
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`oral administration and increases NAD+ biosynthesis upon oral
`administration. Id. at col. 53, l. 66 – col. 54, l. 59.
`As discussed above, we have construed the claim term “isolated”
`when read in light of the Specification of the ’807 patent to require that the
`nicotinamide riboside be separated or substantially free from at least some of
`the other components associated with the source of the molecule such that it
`constitutes at least 25% (w/w) of the composition. Although Petitioner has
`offered evidence that the skim milk disclosed in Goldberger et al. comprises
`nicotinamide riboside that has been separated from fat, it does not teach that
`the nicotinamide riboside comprises at least 25% of the skim milk, nor do
`the other Trammell references on which Petitioner relies to show the
`inherent presence of nicotinamide riboside in Goldberger et al.’s skim milk.
`See Pet. 10. In fact Trammell I suggests that the amount of nicotinamide
`riboside present in raw cow’s milk is less than 25%. See Ex. 1007, 3 (Milk
`samples contain 4.3 ± 2.6 µmol of nicotinamide riboside/liter.). Thus on the
`record before us, Petitioner has not shown that nicotinamide riboside in skim
`milk is “isolated” as required by claim 1.
`Claims 2 and 3 depend from claim 1 and include the limitation
`“isolated nicotinamide riboside.” For the reasons discussed above,
`Petitioner has not shown a reasonable likelihood that it will prevail in
`showing that claims 2 and 3 are anticipated by Goldberger et al.
`
`B. Anticipation by Goldberger and Tanner
`
`Goldberger and Tanner reports a study as to whether certain foods
`could be used to treat and prevent pellagra. Ex. 1006, 87. One of the foods
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`found to be effective in treating and preventing pellagra was buttermilk. Ex.
`1006, 93. Subsequent research revealed that the buttermilk used by
`Goldberger and Tanner contains significant amounts of nicotinamide
`riboside, a precursor of NAD+. Ex. 1007 at 3, 5, and 6.
`Petitioner contends that all of the limitations of claims 1–3 are
`disclosed by Goldberger and Tanner. Pet. 18–28. We are not persuaded that
`Petitioner has shown sufficiently, on the present record and for purposes of
`the present decision, that Goldberger and Tanner discloses all of the
`limitations of claims 1–3. In particular, although Petitioner has offered
`evidence that the buttermilk disclosed in Goldberger and Tanner comprises
`nicotinamide riboside that has been separated from fat, it does not teach that
`the nicotinamide comprises at least 25% of the skim milk, nor do the other
`Trammell references on which Petitioner relies to show the inherent
`presence of nicotinamide riboside in Goldberger and Tanner’s buttermilk.
`See Pet. 20. In fact, as set forth above, Trammell I suggests that the amount
`of nicotinamide riboside present in raw cow’s milk is less than 25%. See
`Ex. 1007, 3 (Milk samples contain 4.3 ± 2.6 µmol of nicotinamide
`riboside/liter.). Thus on the record before us, Petitioner has not shown that
`nicotinamide riboside in buttermilk is isolated as required by claim 1.
`Claims 2 and 3 depend from claim 1 and include the limitation
`isolated nicotinamide riboside. For the reasons discussed above, Petitioner
`has not shown a reasonable likelihood that it will prevail in showing that
`claims 2 and 3 are anticipated by Goldberger and Tanner.
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`CONCLUSION
`For the forgoing reasons, we conclude that Petitioner has not
`established a reasonable likelihood of prevailing on its assertion that claims
`1–3 of the ’807 patent are anticipated by Goldberger et al. We also conclude
`that Petitioner has not established a reasonable likelihood of prevailing on its
`assertion that claims 1–3 of the ’807 patent are anticipated by Goldberger
`and Tanner.
`
`ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’807 patent and no trial is instituted.
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`PETITIONER
`Brendan T. Jones, Esq.
`Donald R. Ware. Esq.
`Jeremy A Younkin, Esq.
`FOLEYHOAG LLP
`bjones@foleyhoag.com
`DRW@foleyhoag.com
`jyoungkin@foleyhoag.com
`
`
`PATENT OWNER
`
`John L. Abramic, Esq.
`James R. Nuttall, Esq.
`Harold H. Fox, Esq.
`STEPTOE AND JOHNSON LLP
`jabramic@steptoe.com
`jnutall@steptoe.com
`hfox@steptoe.com
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