Trials@uspto.gov
`571-272-7822
`
`Paper 48
`Entered: August 10, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`THORNE RESEARCH, INC,
`Petitioner,
`v.
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`
`IPR2021-00491
`Patent 8,197,807 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318 (a)
`Dismissing-in-Part and Denying-in-Part Petitioner’s Motion to Exclude
`Dismissing Patent Owner’s Motion to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
`571-272-7822
`
`Paper 48
`Entered: August 10, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`THORNE RESEARCH, INC,
`Petitioner,
`v.
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`
`IPR2021-00491
`Patent 8,197,807 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318 (a)
`Dismissing-in-Part and Denying-in-Part Petitioner’s Motion to Exclude
`Dismissing Patent Owner’s Motion to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
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`IPR2021-00491
`Patent 8,197,807 B2
`
`INTRODUCTION
`I.
`A. Background and Summary
`Thorne Research, Inc. (“Petitioner”) filed a Petition requesting inter
`partes review of claims 1–3 of U.S. Patent No. 8,197,807 B2 (Ex. 1001, “the
`’807 patent”). Paper 2 (“Pet.”). The Trustees of Dartmouth College (“Patent
`Owner”) filed a Preliminary Response contending that the Petition should be
`denied. Paper 10 (“Prelim. Resp.”). During a telephone conference held on
`March 23, 2021, the panel authorized additional briefing on whether certain
`references were the works “by another” as the term is used in 35 U.S.C.
`§ 102(a) and § 102(e). 1 In accordance with such authorization, Petitioner
`filed a Reply to Patent Owner’s Preliminary Response. Paper 17 (“Pet.
`Reply”). Patent Owner then filed a Sur-Reply. Paper 15 (“PO Sur-Reply”).
`We then issued a decision granting inter partes review on August 12, 2021.
`Paper 18 (“Dec.”).
`Patent Owner subsequently filed a Response, Paper 22 (“PO Resp.”)
`followed by a Reply filed by the Petitioner, Paper 27 (“Reply”) and a Sur-
`Reply by the patent Owner. Paper 31 (“Sur-Reply”). An oral hearing was
`conducted on May 17, 2022. A copy of the transcript has been made of
`record. Paper 47 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. This is a Final Written
`Decision under 35 U.S.C. § 318(a) as to the patentability of the claims on
`which we instituted trial. Based on the complete record before us, we
`determine that Petitioner has not shown, by a preponderance of the evidence,
`
`
`1 35 U.S.C. § 112 was amended by the Leahy-Smith America Invents Act
`(“AIA”), Pub. L. No. 112-29, 125 Stat. 284, 287–88 (2011). Because the
`’807 patent was filed before the effective date of the relevant amendment,
`the pre-AIA versions of §§ 102 and 103 apply in this proceeding.
`2
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`IPR2021-00491
`Patent 8,197,807 B2
`that claims 1–3 are unpatentable. In addition, for the reasons explained
`below, we dismiss-in-part and deny-in-part Petitioner’s Motion to Exclude
`Evidence and dismiss Patent Owner’s Motion to Exclude Evidence.
`B. Real Parties in Interest
`Thorne Research, Inc. identifies itself as the real party-in-interest.
`Pet. 33. The Trustees of Dartmouth College identifies itself as the real party-
`in-interest. Paper 5, 2.
`
`C. Related Matters
`A petition for inter partes review was filed by a third party
`challenging all of the claims of the ’807 patent in IPR2017-01796. Pet. 36.
`We denied institution of inter partes review of the petition in IPR2017-
`01796. Elysium Health, Inc. v. Trustees of Dartmouth College, IPR2017-
`01796, Paper 9 (PTAB Jan. 18, 2018).
`A petition for inter partes review was also filed by the third party
`challenging all claims (1–5) of related U.S. Patent No. 8,383,086 (“the ’086
`patent”) in IPR2017-01795 (“the ’1795 IPR”). Pet. 36. We issued a final
`decision holding that all claims were unpatentable except claim 2. Ex. 1018.
`That decision was affirmed by the Federal Circuit on March 6, 2020.
`Ex. 1020, 1–2.
` Additionally, Petitioner filed its own petition for inter partes review
`of the ’086 patent in IPR2021-00268 filed February 1, 2021. Pet. 36. We
`issued judgment in that case on May 31, 2022. Thorne Research, Inc. v.
`Trustees of Dartmouth College, IPR2021-00268, Paper 63 (PTAB May 31,
`2022).
`Patent Owner states that the ’807 patent and the related ’086 patent
`are the subject of an infringement action in the United States District Court
`for the District of Delaware in a case captioned ChromaDex, Inc., et al. v.
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`Elysium Health, Inc., No. 18-cv-01434 (D. Del.). Paper 5, 3. Patent Owner
`further states that the ’086 patent is also subject to a patent misuse
`counterclaim in ChromaDex, Inc. v. Elysium Health, Inc., No. 16-cv-02277-
`CJC (C.D. Cal.). Id. Patent Owner has also indicated that it has filed an
`action against Petitioner for infringement of the ’086 patent and the ’807
`patent in ChromaDex, Inc., et al. v. Thorne Research, Inc., No. 1:21-cv-
`04241 (S.D.N.Y.). Paper 13.
`Petitioner represents that the district court in the Delaware action
`granted Elysium Health’s Motion for Summary Judgment of Invalidity of
`claim 2 of the ’086 patent, and claims 1, 2, and 3 of the ’807 patent as
`invalid under 35 U.S.C. § 101 for claiming patent ineligible subject matter.
`Paper 25, 2. Patent Owner has appealed the district court’s decision. Id.
`D. The ’807 Patent
`The ’807 patent issued on June 12, 2012, with Charles M. Brenner
`listed as the inventor. Ex. 1001, codes (45), (75). The ’807 patent issued
`from an application filed on April 20, 2006. Id. at code (22). As discussed in
`Section II.C.1, below, the parties disagree as to whether the ’086 patent is
`entitled to an earlier priority date of April 25, 2005.
`The ’807 Patent relates generally to the production of nicotinamide
`riboside (“NR”) and compositions containing NR. Ex. 1001, col. 3, l. 1– col.
`4, l. 16. The ’807 patent also describes the use of compositions containing an
`effective amount of NR to treat various disorders stemming from a
`deficiency in NR. Id. at col. 4, ll. 26–36. NR has been shown to be a
`precursor of nicotinamide adenine dinucleotide (NAD+). Id. The
`compositions can be in the form of a dietary supplement, such as ingestible
`tablets, buccal tablets, troches, capsules, elixirs, suspensions, syrups, wafers,
`chewing gums, and food. Id. at col. 4, ll. 14–16, col. 30, ll. 19–56.
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`E. 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.
`F. Evidence
`Petitioner relies on the following references:
`Brenner, et al., WO 2005/077091 A2, published August 25, 2005.
`(“PCT Publication”) (Ex. 1007).
`Bieganowski et al., Discoveries of Nicotinamide Riboside as a
`Nutrient and Conserved NRK Genes Establish a Preiss-Handler
`Independent Route to NAD+ in Fungi and Humans, 117 Cell 495–502 (May
`14, 2005) (“Cell Article”) (Ex. 1008).
`Rosenbloom, US2003/0185918 A1, published October 2, 2003
`(“Rosenbloom”) (Ex. 1015).
`Petitioner also relies on the Declaration of Dr. Samie Jaffrey, M.D.,
`Ph.D. (Ex. 1002).
`Patent Owner relies of the Declarations of Dr. Charles M. Brenner and
`Dr. Pawel Bieganowski. (Exs. 2002, 2003, 2015, 2020 and 2021).
`
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`Patent 8,197,807 B2
`G. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1–3 would have been unpatentable on the
`following grounds:
`Claim(s) Challenged
`1–3
`1–3
`
`Reference(s)/Basis
`Cell Article, Rosenbloom
`PCT Publication
`
`35 U.S.C. §
`103(a)
`102
`
`
`
`II. ANALYSIS
`A. Legal Standards
`1. Burden of Proof
`At this stage of the proceeding, the burden rests on the petitioner to
`establish by a preponderance of the evidence that claims 1–3 are
`unpatentable. 35 U.S.C. § 316(e).
`2. Anticipation
`“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). “[U]nless a reference
`discloses within the four corners of the document not only all of the
`limitations claimed but also all of the limitations arranged or combined in
`the same way as recited in the claim, it cannot be said to prove prior
`invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C.
`§ 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir.
`2008).
`
`3. Obviousness
`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,
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`(3) the level of skill in the art, and (4) where in evidence, so-called
`secondary considerations or objective indicia of non-obviousness. Graham
`v. John Deere Co., 383 U.S. 1, 17–18 (1966). 2 If the differences between the
`claimed subject matter and the prior art are such 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,
`the claim is unpatentable under 35 U.S.C. § 103(a). KSR Int’l Co. v. Teleflex
`Inc., 550 U.S. 398, 406 (2007).
`A proper § 103 analysis requires “a searching comparison of the
`claimed invention—including all its limitations—with the teaching of the
`prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
`“Obviousness requires more than a mere showing that the prior art
`includes separate references covering each separate limitation in a claim
`under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
`1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing
`that a person of ordinary skill at the time of the invention would have
`selected and combined those prior art elements in the normal course of
`research and development to yield the claimed invention.” Id.
`B. Claim Construction
`For petitions filed on or after November 13, 2018, we interpret claim
`terms using “the same claim construction standard that would be used to
`construe the claim in a civil action under 35 U.S.C. 282(b), including
`construing the claim in accordance with the ordinary and customary
`
`
`2 Patent Owner does not present evidence of secondary considerations or
`objective indicia of non-obviousness in this proceeding. See generally PO
`Resp.
`
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`Patent 8,197,807 B2
`meaning of such claim as understood by one of ordinary skill in the art and
`the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b).
`In IPR2017-01796, we construed the term “isolated” as it appears in
`the ’807 patent to require 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.” See IPR2017-01796, Paper 9 (Decision Denying Institution of
`Inter Partes Review), 5–8. The district court in one of the parallel litigations
`has since construed “isolated nicotinamide riboside” as “nicotinamide
`riboside that is separated or substantially free from at least some of the other
`components associated with the source of the nicotinamide riboside.”
`Ex. 1031, 2.
`It is unclear whether Petitioner urges us maintain the same
`construction for this proceeding as our construction in IPR2017-01796,
`which was based on the broadest reasonable interpretation standard that was
`in effect at the time. See Pet. 38–39 (indicating that the Board’s prior
`constructions “were observed in the unpatentability analysis presented in this
`Petition”). Petitioner, however, notes that “[a]lthough the claims were
`construed under the broadest reasonable construction standard, the
`constructions adopted by the Board in that proceeding are consistent with the
`disclosure of the ’807 patent, as well as how a POSA [person of ordinary
`skill in the art] would have understood those terms.” Id. Patent Owner does
`not propose its own claim constructions or otherwise dispute Petitioner’s
`contentions regarding claim construction in this proceeding. See generally
`PO Resp. For purposes of our analysis in this Decision, we maintain our
`prior construction at least to the extent that it is consistent with the district
`court’s construction. That is, we determine that “isolated nicotinamide
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`riboside” as recited in the claims require “nicotinamide riboside that is
`separated or substantially free from at least some of the other components
`associated with the source of the nicotinamide riboside.” However, our
`analysis below would not differ if we had adopted our original construction
`in its entirety.
`We do not find a need to construe any other claim terms. See Realtime
`Data, LLC v. Iancu, 912 F.3d 136 8, 1375 (Fed. Cir. 2019) (“The Board is
`required to construe ‘only those 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))).
`C. Are the Cell Article and the PCT Publication Prior Art?
`The parties disagree as to whether the Cell Article and the PCT
`Publication relied upon for the challenges set forth in the Petition are prior
`art to the ’807 patent. Petitioner asserts that the ’807 patent is entitled to an
`effective filing date of April 20, 2006. Pet. 8–17. Based on this effective
`filing date, Petitioner asserts that the Cell Article is available as prior art
`under 35 U.S.C.§ 102(b) because it was published more than one year
`earlier, on May 14, 2004. Id. at 32 n.10. Petitioner also contends the PCT
`Publication is prior art under 35 U.S.C. § 102(a) or § 102(e) based on its
`publication date of August 25, 2005. Id. at 34–35 n.12.
`Patent Owner contends that the effective filing date of the ’807 patent
`is April 25, 2005. Prelim. Resp. 29. Patent Owner contends that based on
`this effective filing date, the Cell Article is not prior art under 35 U.S.C.
`§ 102(b). Id. Patent Owner also contends that the Cell Article and the PCT
`Publication are not prior art under 35 U.S.C. § 102(a) or § 102(e) as the
`relevant portions of the Cell Article and the PCT Publication are not “by
`another” as that term is used in the statute. PO Sur-Reply 1.
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`Patent 8,197,807 B2
`Before we can reach the merits of Petitioner’s claims, we must first
`address the issues of (1) the effective filing date of the ’807 patent, and
`(2) whether the relevant portions of the Cell Article and the PCT Publication
`are “by another.”
`1. The Effective Filing Date of the ’807 patent
`The issue of the effective filing date is important in determining
`which provisions of 35 U.S.C. § 102 are applicable. For example, if we
`accept Patent Owner’s argument that the effective filing date of the ’807
`patent is April 25, 2005, the Cell Article is only prior art under 35 U.S.C.
`§ 102(a), making the Cell Article subject to the “by another analysis” set
`forth below. See 35 U.S.C. § 102(a). If, however, we find that the effective
`filing date of the ’807 patent is April 20, 2006, the Cell Article is prior art
`under 35 U.S.C. § 102(b) and the “by another analysis” is not applicable. See
`35 U.S.C. § 102(b). 3
`Petitioner contends that the ’807 patent is entitled to a priority date of
`April 20, 2006, the filing date of U.S. Application No. 11/912,400. (“the
`’400 application”). Pet. 8. Petitioner contends that operation of both the
`Paris Convention and the Patent Cooperation Treaty (“PCT”) precludes any
`claim of priority earlier than that date because the priority chain of the ’807
`patent includes two PCT applications. Id. at 8–18.
`In our Decision to Institute, we did not address the effective filing
`date of the ’807 patent as we preliminarily determined, based on the record
`at the time, that the Cell Article (“Biegenowski”) and the PCT Publication
`
`
`3 The PCT Publication was published August 25, 2005, thus it is one prior
`art under 35 U.S.C. § 102(a) or (e) and is only available if it represents the
`work of another. See 35 U.S.C. § 102(a) and (e). This is true regardless of
`whether the priority date of the ’807 patent is April 2005 or April 2006.
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`(“Brenner”) were available as prior art under either 35 U.S.C. § 102(a) or
`102(e) even assuming Patent Owner’s contention that the effective filing
`date is April 25, 2005. Id. at 13.
`Patent Owner contends that the recited provisions of the Paris
`Convention and PCT are not applicable to the ’807 patent, as the claim of
`priority arises under 35 U.S.C. § 120 and not 35 U.S.C. § 119. PO Resp.
`30–33. Patent Owner contends the ’807 patent meets the requirements of
`35 U.S.C. § 120. Id. at 35–37. Patent Owner contends the priority date of the
`’807 patent is April 25, 2005, which is the filing date of U.S. Application
`No. 11/113,701 (“the ’701 application”). Id. at 37–38.
`In its Reply, Petitioner renews its contention that the ’807 patent is
`only entitled to a filing date of April 20, 2006. Reply 2. In support of its
`contention, Petitioner points to the cover sheet of the ’807 patent, which
`only claims priory back to the PCT application, which was filed on April 26,
`2006, and which in turn claims priority back to the ’701 application. Id. at 2–
`3. Petitioner contends that Patent Owner requested a corrected filing receipt
`for the ’807 patent to claim priority back to the ’701 application, but the
`request was denied. Id. at 3–4. Petitioner contends:
`The priority grants by the USPTO for both the ’086 and
`’807 patents are consistent with Article 4 of the Paris
`Convention. PO [Patent Owner] was put on notice through the
`corrected filing receipts issued by the USPTO and has failed to
`take any corrective action. IPR2015-00414, Paper 34, 15
`(noting, in denying priority, PO could have sought certificate of
`correction or reissue, but failed to do so); Braun v. Becton,
`Dickinson and Co., 1:16-cv-411-RGA, 7 (D. Del. June 9, 2017)
`(citing IPR2015-00414 for same proposition). PO’s arguments
`otherwise should be rejected.
`Id. at 4.
`
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`In its Sur-reply, Patent Owner contends that Petitioner is improperly
`raising a new argument based on Office filing receipts. Sur-reply 1. Patent
`Owner contends that the ’807 patent makes a proper claim of priority under
`35 U.S.C. § 102, and the Board’s initial decision regarding the filing date of
`the ’807 patent was correct. Id at 2.
`We have considered the arguments presented by the parties and,
`similar to our conclusion for the ’086 patent in IPR2021-00268, find that the
`’807 patent is entitled to an effective filing date of April 25, 2005 based on
`priority to the ’701 application.
`The ’807 patent claims priority to domestic applications involving
`either US patent applications or a PCT application designating the United
`States. See Ex. 1001, col. 1, ll. 7–13.
`Under § 120, a patent is entitled to the priority date of an
`earlier filed application if (1) the written description of the
`earlier filed application discloses the invention claimed in the
`later filed application sufficient to satisfy the requirements of
`§ 112; (2) the applications have at least one common inventor;
`(3) the later application is filed before the issuance or
`abandonment of the earlier filed application; and (4) the later
`application contains a reference to the earlier filed application.
`In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C.
`§ 120 (2018). As discussed above, the ’807 patent meets all four criteria set
`forth above for each application in the priority chain of the PCT application
`listed on the face of the ’807 patent. Since the claim of priority arises under
`Section 120, the provisions of the Paris Convention and PCT do not apply.
`While we agree with Petitioner that the face of the ’807 patent does
`not include a citation of the ’701 application, the Specification does contain
`a clear claim of priority back to the ’701 application. See Ex. 1001, col. 1.,
`
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`ll. 11–19. We find that this clear statement is enough for a claim of priority
`to this earlier application for the ’807 patent under 35 U.S.C. § 120.
`Petitioner cites to Apple Inc. v. e-Watch, Inc., IPR2015-00414, Paper
`34 (PTAB June 22, 2016) (“Apple”) to support its contention that Patent
`Owner’s failure to seek correction of the priority claim on the face of the
`’807 patent is fatal to Patent Owner’s claim that the filing date should stretch
`back to April 25, 2005. See Reply 2. The facts in Apple are distinguishable
`from the present case. In Apple, the priority claim in the specification
`misidentified the application as a divisional of a prior application when in
`fact it was not. Apple, Paper 34, 7. The Board found this error in identifying
`the relationship of the applications was fatal to the patent owner’s priority
`claim. Id. at 17.
`This is in contrast to the present case where the specification properly
`identifies each of the prior applications and states the claim of priority. Ex,
`1001, col. 1, ll. 11–19. As the Board in Apple pointed out, pre-AIA
`35 U.S.C.§ 120 stated an application is entitled to the benefit of the filing
`date of the first application “if filed before the patenting or abandonment of
`or termination of proceedings on the first application or on an application
`similarly entitled to the benefit of the filing date of the first application and
`if it contains or is amended to contain a specific reference to the earlier filed
`application.” Apple, Paper 34, 9 (quoting 35 U.S.C. § 120). In the present
`case, the specification contains a specific reference to the chain of
`applications extending back of the ’701 application with appropriate co-
`pendency of the applications in the chain.
`We are unpersuaded by Petitioner’s argument that the Office’s denial
`to grant Patent Owner a corrected filing receipt supports its argument that
`the effective filing date should be April 20, 2006. Reply 3–4. The Office’s
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`refusal to grant a corrected filing receipt was not based on an analysis of
`Patent Owner’s priority claim, but on the grounds that Patent Owner failed
`to file an amended Application Data Sheet. Ex. 1020, 130.
`Based on the foregoing, we determine that the ’807 patent is entitled
`to a filing date of April 25, 2005. Given that the Cell Article was published
`on May 14, 2004, less than one year before the effective filing date of the
`’807 patent, the Cell Article is prior art only under 35 U.S.C.§ 102(a) if it is
`the work of another. 4
`2. Are the Relevant Portions of the References “By Another”?
`Under § 102(e), a claim is invalid only if “the invention was described
`in … an application for patent, published under section 122(b), by another
`filed in the United States before the invention by the applicant for patent.”
`Thus, an applicant or patentee may “overcome a prior art reference under
`section 102(e)” by “establish[ing] that the relevant disclosure describes their
`own invention.” In re Costello, 717 F.2d 1346, 1351 (Fed. Cir. 1983).
`As with § 102(e), one’s own work is also not prior art under § 102(a).
`In re Katz, 687 F.2d 450, 454 (CCPA 1982) (“[O]ne’s own work is not prior
`art under § 102(a) even though it has been disclosed to the public in a
`manner or form which otherwise would fall under § 102(a).”). Thus, a
`patentee may overcome a prior art reference under § 102(a) the same way as
`described above, i.e., by establishing that the relied-upon portions of the
`reference describe their own invention as opposed to the work of another.
`See id. at 455.
`
`
`4 Section 102(e) does not apply here because the Cell Article is not a
`published “application for a patent” nor a “patent granted on an application
`for a patent” by another). See 35 U.S.C. § 102(e).
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`Determining that the prior art has a different inventive entity on its
`face other than the inventive entity on the challenged patent does not end the
`inquiry. We must also determine “whether the portions of the reference
`relied on as prior art, and the subject matter of the claims in question,
`represent the work of a common inventive entity.” EmeraChem Holdings,
`LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 1345 (Fed. Cir.
`2017) (quoting Riverwood Int'l Corp. v. R.A. Jones & Co., 324 F.3d 1346,
`1356 (Fed. Cir. 2003)); see also Costello, 717 F.2d at 1349 (“An applicant
`may also overcome a reference by showing that the relevant disclosure is a
`description of the applicant’s own work. The pertinent inquiry is
`under 35 U.S.C. § 102(e).”).
`In Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
`1375 (Fed. Cir. 2015), the Federal Circuit explained the shifting burden of
`production in an inter partes review with respect to showing whether a
`reference is prior art. Id. at 1379–80. Here, although the burden of
`persuasion never shifts to Patent Owner, Petitioner satisfied its initial burden
`of production by arguing that the PCT Publication (referred to in the Petition
`as “Brenner”) and the Cell Article (referred to in the Petition as
`“Bieganowski”) are prior art to the ’807 patent. See id. at 1379 (stating the
`petitioner satisfied its initial burden of production by arguing that the prior
`art anticipated or rendered obvious the challenged claims); see also Pet. 32
`n.10 and 34 n.12 (contending that the Cell Article and the PCT Publication
`both qualify as prior art). The burden of production then shifted to Patent
`Owner to argue or produce evidence that the PCT Publication and the Cell
`Article are not prior art. With Patent Owner having argued and produced
`evidence that the Cell Article and the PCT Publication are not prior art
`because they are not work “by another,” the burden of production shifted
`15
`
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`back to Petitioner to prove that the Cell Article and the PCT Publication
`constitute prior art. See Dynamic Drinkware, 800 F.3d at 1380.
`Under this burden-shifting framework, we consider the arguments and
`evidence presented by the parties as to whether the PCT Publication and the
`Cell Article are prior art.
`The PCT Publication lists Dr. Brenner and Dr. Bieganowski as co-
`inventors. Ex. 1007, code (75). The Cell Article also lists Dr. Brenner and
`Dr. Bieganowski as co-authors. Ex. 1008, 495. The ’807 patent, however,
`lists Dr. Brenner as the sole inventor. Ex. 1001, code (75). Thus, we agree
`with Petitioner that the asserted references, on their face, list different
`inventive entities than the ’807 patent. See Pet. 32 n.10, 34 n.12. As
`explained above, however, that does not end the analysis. See EmeraChem,
`859 F.3d at 1345. We must now determine whether the portions of the
`references relied upon by Petitioner in the challenges asserted in the Petition
`represent the work of Dr. Brenner. See id.
`a) The Cell Article
`In the Petition, Petitioner relies on at least six passages of the Cell
`Article for its assertion that the claims of the ’807 patent are unpatentable.
`Pet. 40–50; Ex. 1002 ¶¶ 74–93. Petitioner focuses of the portions of the Cell
`Article that relate to compositions containing NR and their use in elevating
`NAD+ levels in humans. See id.
`To satisfy its burden of production to show that the Cell Article’s
`disclosure of NR containing compositions is not the work of another, Patent
`Owner submitted two declarations by Dr. Brenner (Exs. 2002 and 2015) and
`one declaration by Dr. Bieganowski (Ex. 2003). See PO Resp. 14–18.
`Relying on this evidence, Patent Owner asserts that the portions of the Cell
`Article relied upon by Petitioner are solely the work of Dr. Brenner. Id.
`16
`
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`In both his First Declaration (submitted prior to institution) and his
`Second Declaration (submitted after institution), Dr. Brenner testified that he
`was solely responsible for the NR research project related to the
`identification of NR as a compound of interest and therapeutic uses of
`compositions comprising NR. Ex. 2002 ¶ 14; Ex. 2015 ¶ 12. Dr. Brenner
`testified that Dr. Bieganowski only acted on his direction and did not
`contribute to or conceive of any aspect to the NR research regarding the
`therapeutic uses of NR. Ex. 2002 ¶ 14; Ex. 2015 ¶¶ 4, 11–12. For example,
`in his Second Declaration, Dr. Brenner testified as follows:
`
`All of the ideas to conduct these experiments were mine
`alone. I was the person who identified nicotinamide riboside as
`a particular compound of interest and came up with the plan for
`locating and identifying the nicotinamide riboside kinase gene.
`I then directed others in my lab, including post-doctoral fellow
`Pawel Bieganowski, to conduct specific experiments to locate
`the gene. After Dr. Bieganowski performed the assays that I
`directed him to perform and after the nicotinamide riboside
`kinase gene was located, I also directed Dr. Bieganowski to
`perform additional experiments using milk to locate a natural
`source of nicotinamide riboside.
`The idea for therapeutic uses and compositions of
`nicotinamide riboside, including the therapeutic compositions
`recited in the claims of the ’807 patent, were mine alone.
`Although there were other scientists that worked for me in my
`lab at Dartmouth and that performed experiments and assays as
`part of my NR research project, I came up with the ideas for
`that work independently from those other scientists. With
`respect to Dr. Bieganowski, I came up with the specific
`experiments and assays that I thought were appropriate for
`carrying out my ideas, and Dr. Bieganowski faithfully executed
`those experiments and assays at my direction and under my
`supervision.
`Ex. 2015 ¶¶ 11–12.
`
`17
`
`
`
`
`IPR2021-00491
`Patent 8,197,807 B2
`With respect to the disclosure in the Cell Article, Dr. Brenner testified
`that he performed studies to establish that NR is a NAD+ precursor in a
`previously unknown eukaryotic NAD+ synthetic pathway. Ex. 2015 ¶ 30.
`Dr. Brenner testified he then set out to find sources of NR that could be used
`in a therapeutic composition. Id. Dr. Brenner testified that he directed
`Dr. Bieganowski to perform the experiments reported in the Cell Article,
`which confirmed that NR could be used in a therapeutic composition. Id.
`In his testimony Dr. Brenner explains in detail how each portion of
`the Cell Article cited in the Petition was his own work. Id. ¶¶ 31–34. For
`example, Dr. Brenner testified:
`The IPR Petition also relies on language from page 499
`of the Cell article, including the disclosure that “[w]e used the
`yeast qns1 mutant to screen for natural sources of nicotinamide
`riboside and, as shown in Figure 5, we found it in a vitamin
`fraction of cow’s milk” and that “[t]he persistence of ‘niacin’ as
`a mixture of nicotinamide and nicotinic acid may attest to the
`utility of utilizing multiple pathways to generate NAD+ and
`suggests that supplementation with nicotinamide riboside as [a]
`third importable NAD+ precursor may be beneficial for certain
`conditions.” Ex. 1008 at 499; see Petition at 33, 41, 43-44, 48.
`This is the portion of the Cell article that specifically describes
`the screening assay that I alone developed to locate sources of
`nicotinamide riboside that could ultimately be used in
`therapeutic compositions in humans. As I have previously
`described, I developed that assay myself and Dr. Bieganowski
`performed the assays at my direction. The result of that assay
`revealed that nicotinamide riboside is found in milk in trace
`amounts, while the other previously-known NAD+ precursors
`(i.e., nicotinic acid and nicotinamide) did not score positively in
`the pathway-specific assay. In light of that discovery, and as I
`reported in the Cell article, I also concluded t
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