Trials@uspto.gov
`571.272.7822
`
`
` Paper No. 9
` Entered: January 29, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`ELYSIUM HEALTH INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
`
`Case No. IPR2017-01795
`Patent 8,383,086 B2
`____________
`
`Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ, and JOHN
`E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`THORNE - EXHIBIT 1023
`
`
`571.272.7822
`
`
` Paper No. 9
` Entered: January 29, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`ELYSIUM HEALTH INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
`
`Case No. IPR2017-01795
`Patent 8,383,086 B2
`____________
`
`Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ, and JOHN
`E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`THORNE - EXHIBIT 1023
`
`
`
`IPR2017-01795
`Patent 8,383,086 B2
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`I.
`
`INTRODUCTION
`
`A. Background
`Elysium Health Inc. (“Petitioner”) filed a Petition requesting inter partes
`review of claims 1–5 of U.S. Patent No. 8,383,086 B2 (“the ’086 patent”).
`Paper 1 (“Pet.”). The Trustees of Dartmouth College (“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 to institute an inter partes review 35 U.S.C. § 314(a),
`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.” Having considered the arguments and the
`evidence presented, for the reasons described below, we determine that
`Petitioner has demonstrated that there is a reasonable likelihood that it would
`prevail with respect to claims 1 and 3– 5 challenged by the Petition.
`Accordingly, we institute an inter partes review of claims 1 and 3–5 of the
`’086 patent.
`
`B. Additional Proceedings
`Petitioner represents that the ’086 patent is at issue in ChromaDex, Inc., v
`Elysium Health, Inc., Case No. 16-cv-02277-KES (C.D. Cal.). Pet. 30.
`Petitioner also represents that a petition for inter partes review has been filed
`challenging related patent U.S. Patent No. 8,197,807, which is now IPR2017-
`01796. Id. We have denied the petition for IPR2017-01796. Elysium Health,
`Inc. v. Trustees of Dartmouth College, Case IPR 2017-01795 (PTAB Jan. 18,
`2018) (Paper 9).
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`C. The ’086 Patent (Ex. 1001)
`The ’086 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 stems from a natural or synthetic source. Ex. 1001, col. 4, ll. 14–16.
`
`D. Illustrative Claim
`Of the challenged claims, claim 1 is independent. Claims 2–5 depend
`from claim 1. Claim 1 is illustrative of the claimed subject matter and reads as
`follows:
`A pharmaceutical composition comprising nicotinamide
`1.
`riboside in admixture with a carrier, wherein said composition is
`formulated for oral administration.
`Ex. 1001, col. 53, ll. 38–40.
`
`E. The Alleged Grounds of Unpatentability
`Petitioner contends that the challenged claims of the ’086 patent are
`unpatentable on the following grounds.1
`References
`Basis
`Goldberger et al.2
`§ 102
`Goldberger and Tanner3
`§ 102
`
`
`Claims Challenged
`1–5
`1–5
`
`
`1 Petitioner supports its challenge with the Declaration of Joseph A. Baur, Ph.D.
`Ex. 1002.
`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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`CLAIM CONSTRUCTION
`
`II.
`A. Legal Standard
`“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.’” (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir.
`2005))). Only terms which are in controversy need to be construed and only
`then to the extent necessary to resolve the controversy. Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
`1. Pharmaceutical Composition
`Claim 1 recites a “pharmaceutical composition comprising nicotinamide
`riboside . . . formulated for oral administration.” Ex. 1001, col. 53, ll. 38–40.
`Claim 3 reads “[t]he pharmaceutical composition of claim 1, wherein the
`formulation comprises a tablet, troche, capsule, elixir, suspension, syrup, wafer,
`chewing gum or food.” Ex. 1001, col. 53, ll. 44–46.
`Petitioner contends that the term “pharmaceutical composition” should
`include food products. Pet. 6–7. As support, Petitioner points to the language
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`of dependent claim 3, which further limits the pharmaceutical composition of
`claim 1 to a Markush grouping that includes food. Id.
`Patent Owner offers no construction for the term “pharmaceutical
`composition” other than to argue that milk is not a pharmaceutical composition.
`Prelim. Resp. 22.
`We agree with Petitioner that, as used in claim 1, the term
`“pharmaceutical composition” includes food products. Not only is this
`construction consistent with the dependent claim 3 it is supported by the
`Specification of the ’086 patent, which states: “For oral therapeutic
`administration, the compound can be combined with one or more carriers and
`used in the form of ingestible tablets, buccal tablets, troches, capsules, elixirs,
`suspensions, syrups, wafers, chewing gums, foods and the like.” Ex. 1001, col.
`29, ll. 43–47.
`
`2. Carrier
`Petitioner offers no specific construction for the term “carrier” but
`appears to construe the term to mean “components that will bind and stabilize
`the compound.” See Pet. 13. Petitioner’s expert, Dr. Baur, appears to derive
`this definition from Trammell I4 which refers to components in milk that bind
`to nicotinamide riboside and improve its stability. Ex. 1002 ¶ 32; Ex. 1007, 5–
`6. Petitioner points to nothing in the Specification of the ’086 patent that
`supports this definition, nor does Petitioner give any examples of a carrier.
`Patent Owner contends that the term “carrier” should be construed to
`mean a “pharmaceutically acceptable carrier.” Prelim. Resp. 6. Patent Owner
`
`
`4 Trammell et al., Nicotinamide Riboside Is a Major NAD+ Precursor Vitamin
`in Cow Milk, 146 J. Nutrit. 965 (2016) (“Trammell I”), Ex. 1007. Citations are
`to the page numbers of the reprint provided as Ex. 1007.
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`contends that the proposed definition is consistent with the wording of the
`claims and use of the term throughout the Specification. Id. at 7–10.
`Specifically, Patent Owner cites to the Specification where it teaches that
`Polypeptides, nucleic acids, vectors, dietary supplements (i.e.
`nicotinamide riboside), and nicotinamide riboside-related prodrugs
`produced or identified in accordance with the methods of the
`invention can be conveniently used or administered in a
`composition containing the active agent in combination with a
`pharmaceutically acceptable carrier. Such compositions can be
`prepared by methods and contain carriers which are well-known in
`the art. A generally recognized compendium of such methods and
`ingredients is Remington: The Science and Practice of Pharmacy,
`Alfonso R. Gennaro, editor, 20th ed. Lippingcott Williams &
`Wilkins: Philadelphia, Pa., 2000.
`
`Prelim. Resp. 8–9 (emphasis added) (quoting Ex. 1001, col. 28, ll. 49–60).
`We have considered the arguments of the parties as well as the intrinsic
`evidence and decline to adopt the construction offered by either party.
`Petitioner’s proposed construction is unsupported by the intrinsic evidence.
`Petitioner has pointed to nothing in the Specification, claims, or prosecution
`history that supports its proposed definition, nor have we found any such
`support.
`With respect to Patent Owner’s proposed construction, we find it gives
`insufficient guidance as to what constitutes a carrier or a pharmaceutically
`acceptable carrier.
`The Specification of the ’086 patent, however, defines both
`pharmaceutically acceptable carrier and carrier as
`a liquid or solid filler, diluent, excipient, or solvent encapsulating
`material, [that] is involved in carrying or transporting the subject
`compound from one organ, or portion of the body, to another
`organ, or portion of the body. Each carrier must be acceptable in
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`the sense of being compatible with the other ingredients of the
`formulation and not injurious to the patient.
`Ex. 1001, col. 28, ll. 61–67. For purposes of this decision we adopt this
`definition for the term carrier.
`
`3. Isolated
`Petitioner contends that the term “isolated” should be construed to mean
`“is separated or substantially free from at least some of the other components of
`the naturally occurring organism.” Pet. 7.
`In support of its contention, Petitioner cites to the Specification where it
`teaches:
`As used herein, an isolated molecule . . . 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 polypeptide 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. 3–12.
`Patent Owner contends that the term “isolated” should be construed to
`mean “fractionated from other cellular components.” Prelim. Resp. 10–11.
`Patent Owner contends that this construction is consistent with the present
`Specification in that the Specification teaches fractionation as a means to
`separate nicotinamide riboside from other components. Id. at 10–13.
`Patent Owner’s proposed construction is too narrow and is not supported
`sufficiently by the Specification of the ’086 patent. While the Specification
`mentions fractionation in connection with separating nicotinamide riboside
`from other naturally occurring components, the fractionation step is only one of
`several steps used to separate nicotinamide amide from a natural source. See
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`Ex. 1001, col. 27, ll. 4–8. Moreover, the Specification states that the method
`cited by Patent Owner is an example of a method to remove the other
`components and specifically teaches that “[i]solated extracts of the natural
`sources can be prepared using standard methods.” Ex. 1001, col. 27, ll. 3–4.
`Thus, the Specification contemplates using methods other than fractionation to
`isolate nicotinamide riboside from a natural source. Finally, fractionation is
`mentioned only with preparing nicotinamide riboside isolated from natural
`sources. No mention is made regarding its applicability to synthetic sources as
`recited in claim 2.
`The term “isolated” as defined and used in the Specification embraces
`compositions containing nicotinamide riboside in which only some of the other
`components of the naturally occurring organism 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. 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 ’086 patent refer to “isolated nicotinamide
`riboside” and not “isolated nicotinamide riboside kinase.” Id. at col. 53 ll. 59–
`60. While 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
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`require separation from “some”—no matter how insignificant—amount of other
`components of the natural source of nicotinamide riboside (e.g., cow’s milk).
`Thus, based on our consideration of the claim language, the
`Specification, and the parties’ arguments, we determine that the term “isolated”
`should be interpreted to mean 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.
`
`III. ANALYSIS
`
`Petitioner contends that claims 1–5 are anticipated by either Goldberger
`et al. or by Goldberger and Tanner. Pet. 6. As discussed more fully below, we
`conclude that, on the record before us, Petitioner has demonstrated that there is
`a reasonable likelihood that it will prevail on both grounds with respect to
`claims 1 and 3–5. We conclude that Petitioner has not shown that there is a
`reasonable likelihood that it will prevail on either ground with respect to claim
`2.
`
`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
`blacktongue producing diet along with several candidates for preventing
`blacktongue. Ex. 1005, 1387–88. Among the candidates evaluated by
`Goldberger et al. was milk, including skim milk. Id. at 1402–05. Goldberger et
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`al. concluded that skim milk exercised a blacktongue preventative action. Id. at
`1404.
`Subsequent research has shown that one of the components in milk is
`nicotinamide riboside, a precursor of NAD+. Ex. 1007, 3 (Table 1) and 5
`(Table 3). Later studies also show that nicotinamide riboside increases the
`biosynthesis of NAD+. Ex. 1008, 6–7.
`“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 v.
`Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997).
`Petitioner argues that all of the limitations of claims 1–5 are disclosed by
`Goldberger et al. Pet. 8–18. We are 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 and 3–5 arranged as
`in the claim. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370
`(Fed. Cir. 2008). 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 claim 2.
`
`1. Claim 1
`Claim 1 is directed to a pharmaceutical composition comprising
`nicotinamide in admixture with a carrier and formulated for oral administration.
`We consider each of these claim limitations in turn.
`
`a. Pharmaceutical composition
`
`Petitioner contends that the term “pharmaceutical composition” embraces
`foods and that milk, including the skim milk administered in Goldberger et al.,
`is a food. Pet. 11.
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`Patent Owner contends that the term “pharmaceutical composition” does
`not embrace foods, thus, milk is not a pharmaceutical composition. Prelim.
`Resp. 22.
`For purposes of this decision we have construed the term
`“pharmaceutical composition” to include foods when the composition is
`formulated for oral consumption. For purpose of this decision, we find that
`Petitioner has established that the skim milk of Goldberger et al. satisfies the
`claim limitation calling for a pharmaceutical composition.
`
`b. Comprising nicotinamide riboside
`
`Petitioner has produced evidence that nicotinamide riboside is present in
`skim milk. Pet. 12; Ex. 1007, 3 (Table1) and 5 (Table 3). Patent Owner does
`not contest that nicotinamide is present in skim milk. See Prelim. Resp. 22–23.
`For purposes of this decision, we find that Petitioner has established that the
`skim milk in Goldberger et al. that contains nicotinamide riboside satisfies this
`claim element.
`
`c. In admixture with a carrier
`
`Petitioner contends that this limitation is met in that the skim milk of
`
`Goldberger et al. contains nicotinamide riboside in a mixture with other
`components that bind and stabilize the nicotinamide riboside. Pet. 13. To
`support this contention, Petitioner refers to the declaration of Dr. Baur. Id. Dr.
`Baur bases his conclusion that the nicotinamide riboside in Goldberger et al.’s
`skim milk is in admixture with other components of the milk on the teachings
`of Trammell I where it teaches that the other components of milk bind to and
`stabilize the nicotinamide riboside. Ex. 1002 ¶ 32; Ex. 1007, 5–6.
`Patent Owner contends that Petitioner has not shown which of the many
`components in milk act as a carrier. Prelim. Resp. 22–24. Patent Owner also
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`contends that Petitioner has not shown that the milk in Goldberger et al. was
`prepared as an admixture of nicotinamide riboside and a carrier. Id.
`Having considered the parties’ argument and the evidence of record, we
`find that the skim milk in Goldberger et al. comprises nicotinamide riboside in
`an admixture with a carrier. The Specification teaches that “[e]xamples of
`materials which can serve as carriers include sugars, such as lactose.”
`Ex. 1001, col. 29, ll. 1–2. Trammell I teaches that milk contains a combination
`of nicotinamide riboside and other components including lactose. Ex. 1007, 3
`(Table 2). Thus, for purposes of this decision, we determine the milk in
`Goldberger et al. contains nicotinamide riboside in an admixture with a carrier.
`Patent Owner appears to contend that the term “admixture” requires that
`the nicotinamide riboside be purposefully mixed with the carrier. Prelim. Resp.
`24. Patent Owner has not pointed to anything in the record to support its
`contention regarding the meaning of the term “admixture.”
`On the record before us, we find no basis to read the term “admixture” to
`impose a requirement that the ingredients be “purposefully” mixed. Thus, for
`purposes of this opinion, we conclude that the evidence of record demonstrates
`that nicotinamide riboside in Goldberger et al. is in admixture with a carrier.
`
`d. Said composition is formulated for oral consumption
`
`Petitioner contends that this limitation is met in that the skim milk in
`Goldberger et al. was administered orally. Pet. 13–14. In support of this
`contention, Petitioner relies of the Declaration of Dr. Baur who in turn cites to
`Goldberger et al. Id.; Ex. 1002 ¶ 32; Ex. 1005, 1403.
`We agree with Petitioner that skim milk in Goldberger was administered orally.
`Patent Owner does not contest that this claim limitation is met by Goldberger et
`al. See Prelim. Resp. 22–23.
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`We conclude that for purposes of this decision and based on the evidence
`of record, Petitioner has established that Goldberger et al. satisfies this claim
`limitation.
`
`e. Conclusion
`
`Based on the forgoing we conclude that, for purposes of this decision,
`Petitioner has demonstrated a reasonable likelihood that it would prevail in
`showing that clam 1 is anticipated by Goldberger et al.
`
`2. Claim 2
`Claim 2 adds the additional limitation that the nicotinamide riboside is
`isolated from a natural or synthetic source. Ex. 1001, col. 53, ll. 42–43. As
`discussed above, we have defined the term “isolated” to mean 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.
`Petitioner contends that the nicotinamide riboside present in the skim
`milk used by Goldberger et al. is isolated in that the fat contained in whole milk
`has been separated from the nicotinamide. Pet. 14–15.
`Patent Owner contends that skim milk does not satisfy this claim element
`in that the milk has not been fractionated. Prelim. Resp. 25–27.
`As discussed above, we have declined to adopt Patent Owner’s proposed
`construction for the term “isolated” and find Patent Owner’s argument
`unpersuasive as to the broadest reasonable construction of that term.
`With respect to Petitioner’s contention regarding skim milk, while
`Petitioner has offered evidence to show that the nicotinamide riboside in skim
`milk has been separated from at least some of the other components associated
`with nicotinamide riboside, e.g., fat, Petitioner has offered no evidence to show
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`that nicotinamide riboside constitutes at least 25% by weight of the remaining
`composition. In fact, the evidence of record suggests that the nicotinamide
`riboside present is less than 25% by weight. See Ex. 1007, 3 (milk samples
`contained 4.3 ± 2.6 µmol nicotinamide riboside/liter).
`Based on the record before us and for purposes of this decision, we find
`that Petitioner has not demonstrated a reasonable likelihood that it would
`prevail in showing that claim 2 is anticipated by Goldberger et al.
`
`3. Clam 3
`Claim 3, which depends from claim 1, adds the additional limitation that
`the pharmaceutical composition comprises “a tablet, troche, capsule, elixir,
`suspension, syrup, wafer chewing gum or food.” Ex. 1001, col. 53, ll. 44–46.
`Petitioner contends that this element is satisfied by the skim milk of
`Goldberger et al. in that skim milk is a food. Pet. 15. Petitioner relies on the
`Declaration of Dr. Baur to support this contention. Id.; Ex. 1002 ¶ 34. We
`agree that skim milk is a food, and Patent Owner does not contend otherwise.
`See Prelim. Resp. 26.
`We therefore conclude that Petitioner has demonstrated a reasonable
`likelihood that claim 3 is anticipated by Goldberger et al.
`
`4. Claim 4
`Claim 4, which depends from claim 1, adds the additional limitation that
`the pharmaceutical composition comprises “one or more of tryptophan,
`nicotinic acid, or nicotinamide.” Ex. 1001, col. 54, ll. 37–39.
`Petitioner contends that this limitation is met in that the skim milk used
`in Goldberger at al. contains nicotinamide and tryptophan. Pet. 15–16. To
`support this contention Petitioner cites to Trammell I where is states that “[i]t
`has long been known that NAD+ precursors in milk include nicotinamide and
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`tryptophan.” Ex. 1007, 1. We agree that Petitioner has shown sufficiently on
`this record that the skim milk of Goldberger et al. contains nicotinamide and
`tryptophan.
`Patent Owner does not contest Petitioner’s contention with respect to
`claim 4. See Prelim. Resp. 26.
`We therefore conclude that Petitioner has demonstrated a reasonable
`likelihood that claim 4 is anticipated by Goldberger et al.
`
`5. Claim 5
`Claim 5 depends from claim 1 and adds the limitation that the
`pharmaceutical composition “increases NAD+ biosynthesis upon oral
`administration.” Ex. 1001, col. 54, ll. 41–42.
`Petitioner contends that this limitation is inherently met by the skim milk
`used by Goldberger et al. Pet. 16–17. Petitioner relies on the teachings of
`Trammell I to show that milk contains nicotinamide riboside, a precursor of
`NAD+. Pet. 17; Ex. 1007, 6. Trammell II5 and the Brenner Declaration6 are
`relied upon to show that administration of nicotinamide riboside, including oral
`administration, boosts production of NAD+. Ex. 1008, 6–7; Ex. 1003, 133–35.
`Petitioner also relies on the teaching in Goldberger et al. that dogs fed
`skim milk did not experience blacktongue. Pet. 17; Ex. 1005, 1403–04.
`Blacktongue is caused by a deficiency of NAD+. Ex. 1010, 2. Petitioner
`contends that the results in Goldberger et al. are evidence that NAD+
`
`
`5 Trammell et al., Nicotinamide riboside is uniquely and orally bioavailable in
`mice and humans, 7 Nature Comm. Art. 12948 (2016) (“Trammell II”),
`Ex. 1008. Citation are to the page numbers found in the reprint supplied as
`Ex. 1008.
`6 Rule 132 Declaration filed January 16, 2012, Ex. 1003, excerpt of Prosecution
`History of USSN 11/912,400, 133–135.
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`biosynthesis in the subject dogs was increased by administration of skim milk.
`Pet. 17.
`Patent Owner contends that we should decline to consider Petitioner’s
`argument under 35 U.S.C. § 325(d) as the same argument was considered by
`the Examiner during prosecution. Prelim. Resp. 27–28. Patent Owner also
`contends that Petitioner has not established that Goldberger et al. discloses a
`pharmaceutical composition that increases NAD+ biosynthesis upon oral
`administration. Id. at 28.
`We have considered the parties’ arguments and conclude that Petitioner
`has demonstrated a reasonable likelihood it would prevail in showing that claim
`5 is anticipated by Goldberger et al. Goldberger et al. teaches feeding dogs
`skim milk prevents the development of blacktongue, a disease caused by a
`deficiency of NAD+. Ex. 1005, 1403–04; Ex. 1010, 2. The evidence of record
`shows that nicotinamide riboside is present in milk and boosts the production of
`NAD+. Ex. 1007, 6; Ex. 1008, 6–7. We agree with Petitioner on the record
`before us that the consumption of skim milk inherently increases the
`biosynthesis of NAD+.
`With respect to Patent Owner’s argument that we should decline to
`consider Petitioner’s argument under 35 U.S.C. § 325(d) we are not so inclined
`under the present circumstances.
`In determining whether to institute inter partes review, we may “deny
`some or all grounds for unpatentability for some or all of the challenged
`claims.” 37 C.F.R. § 42.108(b); see 35 U.S.C. § 314(a). Our discretionary
`determination of whether to institute review is guided, in part, by 35 U.S.C.
`§ 325(d), which states in relevant part:
`MULTIPLE PROCEEDINGS-- . . . In determining whether to
`institute or order a proceeding under this chapter . . . the Director
`
`16
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`
`
`IPR2017-01795
`Patent 8,383,086 B2
`
`
`may take into account whether, and reject the petition or request
`because, the same or substantially the same prior art or arguments
`previously were presented to the Office.
`35 U.S.C. § 325(d).
`Our discretion pursuant to § 325(d) involves a balance between several
`competing interests. “On the one hand, there are the interests in conserving the
`resources of the Office and granting patent owners repose on issues and prior
`art that have been considered previously.” Fox Factory, Inc. v SRAM, LLC,
`Case IPR2016-01876, slip op. at 7 (PTAB Apr. 3, 2017) (Paper 8). “On the
`other hand, there are the interests of giving petitioners the opportunity to be
`heard and correcting any errors by the Office in allowing a patent—in the case
`of an inter partes review—over prior art patents and printed publications.” Id.
`Patent Owner contends that the Examiner previously considered the
`argument that the skim milk used by Goldberger et al. increases the
`biosynthesis of NAD+. Prelim. Resp. 27. Patent Owner points to the fact that
`the Examiner rejected the pending claims on the grounds that nicotinamide is
`present in milk. Id.; Ex. 1003, 139. Patent Owner overcame this rejection by
`amending the claims to include the limitation calling for increase in NAD+
`biosynthesis and by arguing that there was no evidence of record to show that
`the nicotinamide in milk increases NAD+ biosynthesis. Prelim. Resp. 27–28;
`Ex. 1003, 142, 144. Patent Owner contends that Petitioner’s arguments with
`respect to claim 5 are the same or substantially the same as the Examiner’s
`rejection. Prelim. Resp. 28.
`We have considered Patent Owner’s argument and find it unpersuasive.
`The Examiner’s rejection during prosecution was only based on the proposition
`that milk contained nicotinamide riboside, not that milk increased the
`biosynthesis of NAD+. In fact, Patent Owner was successful in overcoming the
`
`17
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`IPR2017-01795
`Patent 8,383,086 B2
`
`rejection by arguing that there was no evidence of record that consumption of
`milk increased NAD+ biosynthesis. As discussed above, in addressing claim 5,
`Petitioner has provided additional evidence in this proceeding that the
`consumption of milk in fact increases NAD+ biosynthesis. The Examiner did
`not consider this evidence. We conclude that the arguments and evidence
`advanced by the Petitioner are not the same or substantially the same as those
`considered by the Office. We, therefore, do not exercise our discretion under
`35 U.S.C. § 325(d) to deny institution.
`We find that Petitioner has demonstrated a reasonable likelihood it would
`prevail in showing that claim 5 is anticipated by Goldberger et al.
`
`B. Anticipation by Goldberger and Tanner
`Petitioner contends that claims 1–5 are anticipated by Goldberger and
`Tanner as evidenced by Trammell I and Trammell II. Pet. 18–29. In addition
`to the teachings of the references, Petitioner also relies on Dr. Baur’s
`Declaration in support of this challenge.
`The generalized teachings of Goldberger and Tanner that Petitioner relies
`upon for this challenge are similar to the teachings of Goldberger et al.
`Goldberger and Tanner reports a study as to whether certain foods could be
`used to treat and prevent pellagra. Ex. 1006, 87. Like backtongue in dogs,
`pellagra is caused by a deficiency of NAD+. Ex. 1010, 2. One of the foods
`found to be effective in treating and preventing pellagra was buttermilk.
`Ex. 1006, 93. As with skim milk, subsequent research revealed that the
`buttermilk used by Goldberger and Tanner contains significant amounts of
`nicotinamide riboside, a precursor of NAD+. Ex. 1007, 3, 5, and 6.
`Board rules require us to “secure the just, speedy, and inexpensive
`resolution of every proceeding.” 37 C.F.R. § 42.1(b). Petitioner has not
`
`18
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`IPR2017-01795
`Patent 8,383,086 B2
`
`pointed to any material differences between this challenge and the challenge
`based on Goldberger et al. to justify the use of Board and party resources to
`proceed on both challenges. We, therefore, decline to institute on this
`additional anticipation challenge.
`
`IV. CONCLUSION
`
`For the forgoing reasons, we conclude that Petitioner has established a
`reasonable likelihood of prevailing on its assertion that claims 1 and 3–5 of the
`’086 patent are anticipated by Goldberger et al.
`We also conclude that Petitioner has not established a reasonable
`likelihood it would prevail in showing that claim 2 is anticipated by Goldberger
`et al.
`We exercise our discretion under 35 U.S.C. § 314 and decline to institute
`on the anticipation challenge based on Goldberger and Tanner.
`
`V. ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDERED that pursuant to 35 U.S.C. § 314(a) an inter partes review is
`hereby instituted on the following grounds:
`Claims 1 and 3–5 as anticipated by Goldberger et al.; and
`FURTHER ORDERED that the Petition is denied with respect to claim 2
`of the ’086 patent and no trial is i
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