United States Court of Appeals 

for the Federal Circuit ______________________ 

CHROMADEX, INC., TRUSTEES OF DARTMOUTH 

COLLEGE,

Plaintiffs-Appellants

v.

ELYSIUM HEALTH, INC.,

Defendant-Appellee

______________________ 

2022-1116

______________________ 

Appeal from the United States District Court for the 

District of Delaware in No. 1:18-cv-01434-CFC-JLH, Chief 

Judge Colm F. Connolly.

______________________ 

Decided: February 13, 2023

______________________ 

WILLIAM L. MENTLIK, Lerner, David, Littenberg, 

Krumholz & Mentlik, LLP, Cranford, NJ, argued for plaintiffs-appellants. Also represented by RUSSELL W.

FAEGENBURG, STEPHEN F. ROTH; ROBERT JASON FOWLER,

CHRISTOPHER NEIL SIPES, ASHLEY MARIE WINKLER, Covington & Burling LLP, Washington, DC. 

 JEREMY YOUNKIN, Foley Hoag LLP, Boston, MA, argued for defendant-appellee. Also represented by DONALD 

ROSS WARE. 

______________________ 

Case: 22-1116 Document: 44 Page: 1 Filed: 02/13/2023
2 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 

Before PROST, CHEN, and STOLL, Circuit Judges.

PROST, Circuit Judge. 

ChromaDex, Inc. (“ChromaDex”) and the Trustees of 

Dartmouth College (“Dartmouth”) (collectively, “Appellants”) appeal the decision of the U.S. District Court for the 

District of Delaware granting Elysium Health, Inc.’s (“Elysium”) motion for summary judgment that the asserted 

claims of U.S. Patent No. 8,197,807 (“the ’807 patent”) are 

directed to unpatentable subject matter under 35 U.S.C. 

§ 101.1 We affirm.

BACKGROUND

I 

The ’807 patent is directed to dietary supplements containing isolated nicotinamide riboside (“NR”), a form of vitamin B3 naturally present—in non-isolated form—in cow’s 

milk and other products.2 See ’807 patent col. 27 ll. 42–45. 

Animal cells convert ingested NR into the coenzyme nicotinamide adenine dinucleotide, or NAD+. NAD+ deficiencies can cause diseases in both animals and humans.

The asserted claims are claims 1–3 of the ’807 patent. 

Representative claim 1 recites:

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 

1 Appellants also sought review of the district court’s 

invalidation of claim 2 of U.S. Patent No. 8,383,086. The 

voluntary dismissal of a related appeal mooted that part of 

the case. 2 For the sake of brevity, we use the word “milk” in 

the rest of this opinion to describe natural cow’s milk.

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CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 3

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 increased NAD+ 

biosynthesis upon oral administration.

II

ChromaDex sells, among other products, dietary supplements in the form of pharmaceutical compositions of NR 

embodying the ’807 patent. It licenses the patent from 

Dartmouth. Appellants sued Elysium, a former ChromaDex customer, for patent infringement in September 

2018. The district court construed several claim terms; relevant here, the court construed “isolated [NR]” to mean 

“[NR] that is separated or substantially free from at least 

some other components associated with the source of [NR].” 

J.A. 22.

Elysium moved for summary judgment, arguing that 

the asserted claims were invalid under 35 U.S.C. § 101, 

and the district court granted the motion. See ChromaDex, 

Inc. v. Elysium Health, Inc., 561 F. Supp. 3d 460 (D. Del.

2021). The district court concluded that the claims were 

directed to a natural phenomenon, namely, “compositions 

comprising isolated [NR], a naturally occurring vitamin 

present in cow milk.” Id. at 464 (cleaned up). It rejected 

ChromaDex’s argument that the characteristics of isolated 

NR purportedly different from naturally occurring NR—

stability, bioavailability, sufficient purity, and therapeutic 

efficacy—render the claims patent-eligible, observing that 

none of those characteristics were part of the claims. Id.

at 465. It concluded that “the decision to create an oral formulation of NR after discovering that NR is orally bioavailable is simply applying a patent-ineligible law of nature.” 

Id. at 467.

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4 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 

The district court entered judgment of invalidity, and 

this appeal followed.3 We have jurisdiction under 

28 U.S.C. § 1295(a)(1).

DISCUSSION

I 

We review the district court’s grant of summary judgment under the law of the regional circuit, here the Third 

Circuit, which reviews such issues de novo. Junker v. Med. 

Components, Inc., 25 F.4th 1027, 1032 (Fed. Cir. 2022) (citing Gonzalez v. Sec’y of Dep’t of Homeland Sec., 678 F.3d 

254, 257 (3d Cir. 2012)). Summary judgment is appropriate when, drawing all reasonable inferences in the nonmoving party’s favor, “there is no genuine dispute as to any 

material fact and the movant is entitled to judgment as a 

matter of law.” Fed. R. Civ. P. 56(a); Anderson v. Liberty 

Lobby, Inc., 477 U.S. 242, 255 (1986). Eligibility under 

§ 101 may involve questions of fact but is, ultimately, a 

question of law that we review de novo. Nat. Alts. Int’l, Inc. 

v. Creative Compounds, LLC, 918 F.3d 1338, 1342 

(Fed. Cir. 2019); Interval Licensing LLC v. AOL, Inc., 896 

F.3d 1335, 1342 (Fed. Cir. 2018).

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or 

any new and useful improvement thereof, may obtain a 

3 Appellants also challenge the district court’s orders 

granting-in-part Elysium’s motion to dismiss for lack of 

standing and denying its motion for leave to amend, as well 

as one of its claim constructions. The district court’s standing order only dismissed claims of infringement based on 

activities alleged to have occurred on or after March 13, 

2017, see J.A. 16–17, so the eligibility issue remained 

live. Because we affirm the district court’s invalidity judgment, we do not reach either the standing or the claim construction issues.

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CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 5

patent therefor, subject to the conditions and requirements 

of this title.” 35 U.S.C. § 101. “Laws of nature, natural 

phenomena, and abstract ideas,” in contrast, “are not patentable.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013). 

II

The parties agree that NR is naturally present in milk. 

It is undisputed that milk is a naturally occurring product

that is not patent eligible. The parties also acknowledge

that milk contains tryptophan and lactose, a sugar. And

no one disputes that the tryptophan in milk treats NAD+ 

deficiencies. The claims are very broad and read on milk 

with only one difference as shown:

Element Milk

[1p] “A composition 

comprising”

Milk is a composition.

[1a] “isolated [NR]” Milk contains NR, but the 

NR is not isolated. J.A. 

10095.

[1b] “in combination 

with one or more of tryptophan, nicotinic acid, or nicotinamide”

Milk contains tryptophan 

and nicotinamide. J.A. 

10095.

[1c] “wherein said combination is an 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 

Milk is an admixture containing a sugar (lactose). 

J.A. 10096

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6 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 

saline, Ringer’s solution, 

ethyl alcohol, polyester, polycarbonate, or polyanhydride”

[1d] “wherein said composition is formulated for 

oral administration”

Milk is formulated for oral 

administration. See J.A. 

10096.

[1e] “and increases 

NAD+ biosynthesis upon 

oral administration.”

Milk (through tryptophan) 

increases NAD+ biosynthesis upon consumption. See J.A. 10096.

So the only difference between at least one embodiment 

within the scope of the claims and natural milk is that the 

NR in the former is isolated. 

The Supreme Court’s decisions in Myriad and Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), apply here. 

In Chakrabarty, the Court found eligible claims to a genetically engineered bacterium “capable of breaking down 

multiple components of crude oil.” 447 U.S. at 305, 318. 

No naturally occurring bacteria possessed the same property. Id. Accordingly, in the Court’s view, the “claim [was] 

not to a hitherto unknown natural phenomenon, but to a 

nonnaturally occurring manufacture or composition of 

matter—a product of human ingenuity having a distinctive 

name, character and use.” Id. at 309–10 (cleaned up). Because “the patentee ha[d] produced a new bacterium with 

markedly different characteristics from any found in nature and one having the potential for significant utility,” 

the Court upheld the claims. Id. at 310.

As in Myriad, under the circumstances presented here, 

the act of isolating the NR compared to how NR naturally 

exists in milk is not sufficient, on its own, to confer patent 

eligibility. See Myriad, 569 U.S. at 590–93. The claimed 

compositions remain indistinguishable from natural milk 

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CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 7

because, other than separation from some other components, the isolated NR is no different structurally or functionally from its natural counterpart in milk. Chakrabarty 

defines the inquiry: to be patentable, the claimed composition must “ha[ve] markedly different characteristics and 

have the potential for significant utility.” 447 U.S. at 310. 

Milk, like the claimed compositions, undisputedly “increase[s] NAD+ biosynthesis” upon oral administration. 

The claimed compositions do not exhibit markedly different 

characteristics from natural milk and are, therefore, invalid for claiming a patent-ineligible product of nature. Cf. 

Myriad, 569 U.S. at 579 (concluding “that a naturally occurring DNA segment is a product of nature and not patent 

eligible merely because it has been isolated” (emphasis 

added)).

Our Natural Alternatives decision is particularly instructive. There, we upheld, at the motion-to-dismiss 

stage, claims directed to dietary supplements containing 

beta-alanine. See 918 F.3d at 1341. We concluded that the

patents there claimed “specific treatment formulations 

that incorporate[d] natural products” and that those formulations “ha[d] different characteristics and c[ould] be 

used in a manner that beta-alanine as it appears in nature 

cannot.” Id. at 1348. Specifically, the “natural products 

ha[d] been isolated and then incorporated into a dosage 

form”—“between about 0.4 grams to 16 grams”—“with particular characteristics”—namely, to “effectively increase[] 

athletic performance.” Id. at 1348–49. Those markedly different characteristics distinguished the claimed supplements from natural beta-alanine and preserved the claims’ 

validity. Id. at 1349. 

Here, in contrast, the asserted claims do not have characteristics markedly different from milk. Both the claimed 

compositions and milk “increase[] NAD+ biosynthesis upon 

oral administration.” Appellants argue that the claimed 

compositions are advantageous over milk because the isolation of NR allows for significantly more NAD+ 

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8 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 

biosynthesis than is found in milk and that the large quantity of NR itself can alone increase NAD+ biosynthesis. But 

the asserted claims do not require any minimum quantity 

of isolated NR. Nor do these claims attribute the claimed 

increase in NAD+ biosynthesis to the isolated NR, requiring only that the composition increase NAD+ production. 

Because milk increases NAD+ biosynthesis, the claimed 

compositions do not possess characteristics markedly different from those found in nature. To be sure, the claims 

cover several different composition embodiments, some of 

which are structurally different from milk. However, as 

noted above, the claims also encompass—as both parties 

agree—at least one embodiment that covers milk, except 

that the NR element is “isolated.” Because the claims are

broad enough to encompass a product of nature, it is invalid under § 101.

Appellants nonetheless argue that the claims, in fact,

possess markedly different characteristics that render 

them patent-eligible. See Appellants’ Br. 28–31. They base 

this argument on two main points: (1) “NR is found in milk 

in only trace amounts,” i.e., one part per million; and

(2) “what little NR is found in milk is not bioavailable” because it is bound to the lactalbumin whey protein. Id. at 

29.4 The problem for Appellants is two-fold. First, as 

4 Appellants also identify a factual error in the district court’s opinion. The court stated that it was “undisputed that NR in milk . . . enhances NAD+ biosynthesis.” 

ChromaDex, 561 F. Supp. 3d at 465. Appellants correctly 

point out that the NR in milk does not enhance NAD+ biosynthesis, that it argued as much to the district court, and 

that Elysium conceded the point. See, e.g., J.A. 10245 (Elysium admitting that “one can’t eat enough of anything [containing trace amounts of NR] to boost NAD+ levels”). That 

error was harmless, however, because the claims do not require that the NR, specifically, increase NAD+ 

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CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 9

discussed above, milk increases NAD+ biosynthesis (albeit 

because it contains tryptophan rather than because of the 

trace amounts of NR), and that is the only therapeutic effect that the claims require. Second, the claims simply do 

not reflect the distinctions Appellants rely on: they do not 

require any specific quantity of isolated NR, and the district court’s construction for “isolated [NR],” which Appellants do not challenge on appeal, does not require that the 

NR be separated from the lactalbumin whey protein but 

only from “some of the other components associated with 

the source of [NR].” J.A. 22 (emphasis added). The claims, 

therefore, do not necessarily require that the isolated NR 

be bioavailable, meaning that the claimed compositions do 

not necessarily possess markedly different characteristics

from milk, as they must to be patent-eligible.

We conclude that the asserted claims lack markedly

different characteristics from milk. They claim a product 

of nature and are not patent eligible. 

III

The inquiry could end here—the Supreme Court in 

Myriad relied on Chakrabarty’s “markedly different characteristics” framework for analyzing whether the claimed 

compositions there were directed to a natural phenomenon; 

the Court never applied the Alice/Mayo two-step framework despite deciding the case after Mayo. See Myriad, 569 

U.S. at 593–95; see also Alice Corp. Pty. Ltd. v. CLS Bank 

Int’l, 573 U.S. 208, 217 (2014); Mayo Collaborative Servs. 

v. Prometheus Labs., Inc., 566 U.S. 66, 77–80 (2012). But 

if resort to Alice/Mayo is necessary, then at step one we 

conclude the asserted claims are directed to a product of 

nature for the reasons stated above, and at step two the 

claims lack an inventive step because they are directed to 

biosynthesis; it is enough if the claimed composition accomplishes that objective, and milk does so.

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10 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 

nothing more than compositions that increase NAD+ biosynthesis, which is the very natural principle that renders 

the claims patent-ineligible.5

Appellants identify only two possible inventive steps: 

“[1] recognizing the utility of NR for enhancing health and 

well-being and [2] the wisdom of isolating the NR to provide concentrations higher than what occur naturally.” Appellants’ Br. 31 (emphasis original). But recognizing the 

utility of NR is nothing more than recognizing a natural 

phenomenon, which is not inventive. See Myriad, 569 U.S. 

at 591. And the act of isolating the NR by itself, no matter 

how difficult or brilliant it may have been (although the 

specification makes clear that it was conventional), similarly does not turn an otherwise patent-ineligible product 

of nature into a patentable invention. See id. So the claims

would likewise fail at step two.

CONCLUSION

We have considered Appellants’ remaining arguments 

and find them unpersuasive. As Appellants conceded at 

oral argument, our resolution of the patent-eligibility issue 

moots the standing question. For the reasons set forth 

5 In Natural Alternatives, we purported to analyze

the patent-eligibility of the claimed compositions under Alice/Mayo’s two-step framework. See Nat. Alts., 918 F.3d at 

1342, 1348–49. But because we concluded that factual allegations relating to the claimed compositions’ markedly

different characteristics from natural beta-alanine precluded judgment on the pleadings, the analysis functionally examined only the Chakrabarty question. See id. at 

1348. Indeed, in one prior case, we analyzed compositionof-matter claims under Myriad and Chakrabarty but analyzed method claims under Mayo. Compare In re BRCA1- 

and BRCA2, 774 F.3d 755, 759–61 (Fed. Cir. 2014), with

id. at 761–765.

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above, we affirm the district court’s judgment that the asserted claims of the ’807 patent are invalid under 35 U.S.C. 

§ 101. 

AFFIRMED

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