Guest Post by Jordan Duenckel. Jordan is a second-year law student at the University of Missouri, head of our IP student association, and a registered patent agent. He has an extensive background in chemistry and food science.
The Federal Circuit weighed in on the amorphous topic of subject matter eligibility in the recent opinion ChromaDex, Inc., V. Elysium Health, Inc., — F.4th —, Docket No. 2022-1116. Writing for a unanimous panel, Judge Prost affirmed a grant of summary judgment that U.S. Patent No. 8,197,807 (“the ’807 patent”) was directed to unpatentable subject matter and therefore ineligible based on 35 U.S.C. § 101.
ChromaDex’s ‘807 patent concerns nicotinamide riboside (“NR”), a form of vitamin B3 found naturally in cow’s milk. When ingested, a human body converts NR into the coenzyme nicotinamide adenine dinucleotide, or NAD+. Claim one of ‘807 states:
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, … or polyanhydride,
wherein said composition is formulated for oral administration and increased NAD+ biosynthesis upon oral administration.
ChromaDex isolates and concentrates naturally occurring NR — selling dietary supplements that contain elevated levels of NR. The levels found in these supplements is significantly above natural levels present in milk or any other food. Although the claims require isolated NR, they do not require a specific high-concentration, only enough to “increase[] NAD+ biosynthesis upon oral administration.” In its decision, the Federal Circuit focuses on the breadth of the claim and its ability to include natural milk (a product of nature) as the key ingredient providing the NR.
The Supreme Court has two key product of nature cases from the past 45 years: Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
Under these cases, a determination that milk is within the scope of the claims is not, by itself fatal to eligibility. Chakrabarty requires that to be patentable the claimed composition must “ha[ve] markedly different characteristics [from the natural phenomenon] and have the potential for significant utility.” 447 U.S. at 310. The chemical composition of isolated NR is not structurally or functionally different from NR found in milk. ChromaDex’s argument at the district court that the characteristics of isolated NR are purportedly different from naturally occurring NR— stability, bioavailability, sufficient purity, and therapeutic efficacy was rejected because these improvements were not required by the claim language. On appeal, ChromaDex insists in their brief that the claims have “markedly different characteristics” that render them patent eligible, specifically that (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. Again though, ChromaDex’s argument is thwarted by the overly broad claim language. The claims do not require either a minimum level of NR or even that the isolated NR is more bioavailable by separation from the lactalbumin.
The corollary to Chakrabarty is Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) and is more similar to the subject matter of ChromaDex. In Myriad, the isolation of specific DNA fragments was found to be patent ineligible. ChromaDex faces the same problem. The act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility.
Federal Circuit held that this Chakrabarty analysis was dispositive on the question of § 101 eligibility and affirmed the grant of summary judgment. One open question is whether the same two-step analysis of Alice/Mayo applies in the product-of-nature eligibility arena. Without fully deciding that question, the Federal Circuit conducted a subsequent analysis under the Alice/Mayo two-step test and reached the same conclusion — that the claims are ineligible. As noted by this court, the Alice/Mayo test is functionally the same as the Chakrabarty analysis, especially when a composition of matter is at issue.
It appears to me that the primary issue is a patent drafting problem. The ‘807 patent was filed on April 20th, 2006, long before the clarifying guidance from Myriad (2013), Alice (2014), and Mayo (2012). At the time of filing, the isolation and reformulation was not subject to the explicit subject matter restriction in Myriad. However, the patent drafter should have been aware of Chakrabarty (1980). Claim one was written so broadly that potential embodiments include far more than dietary supplement pills.
The Federal Circuit distinguished the current case from Nat. Alts. Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019). In Natural Alternatives, “natural products ha[d] been isolated and then incorporated into a dosage form”—“between about 0.4 grams to 16 grams”—“with particular characteristics to effectively increase athletic performance.” Id. at 1348–49. The patentee may have also avoided an eligibility problem by providing evidence in the specification that the NR concentration in milk was insufficient to increase NAD+ biosynthesis as claimed, but that higher levels of concentration did provide that benefit. To be most clear, the claims could have also added a limitation that the NR is provided in an “effective amount” to achieve the claimed NAD+ synthesis.
Greg, watch the video. Or try to read. There are literally thousands of videos many by full professors at Ivy League schools explaining the neo-Marxist movement in the USA.
The crux of it is that rather than social classes the neo-Marxist are using race and gender to try and force outcomes.
Stumbled across this – it fits Greg perfectly:
Beware of false knowledge; it is more dangerous than 1gn0rance
George Bernard Shaw
link to snopes.com
(on the other hand, Marty is in that domain of 1gn0rance)
So an apparently astute commentariat on this thread (excluding anon by experience) reviews an appellate opinion and applicable law, and arrives at a completely diverse set of opinions. Some say the patent should have been eligible. Some say it should have been invalidated under Section 112, others under Sections 102/103.
That diversity of views is expected happen in politics. Not so much in law.
Not that there is much of a separation in many instances, but in law the expectation is more of a binary disagreement: one side reads it one way, the other side reads it another way.
When ideas are all over the map, it suggests that eligibility is primarily a political problem. That’s how I’ve thought of it.
To me, this patent clearly describes a composition of matter that is anticipated by cow’s milk. So the patent should have been eligible, but invalid under 102. If the claim scope did exclude cow’s milk, the claims would likely be obvious to PHOSITA anyway, since concentrating and delivering useful vitamins via conventional methods is a basic idea known to the art for decades. Suspension or emulsion would be irrelevant to PHOSTA being able to do it without experimentation.
Lawless courts behaving as primary political actors is a much bigger problem than mere patent eligibility, but it’s just another symptom of a dysfunctional Congress and increasingly ungovernable state.
Modern 101 jurisprudence arose mostly with the difficulty of the as-written patent law dealing with new and useful information, but that distortion has metastasized, and what we get is what you see in this thread.
Principled, but utterly unpredictable results in far too many cases.
PS, there is an evolving consensus now (at least) on what WOKE means.
It means Black.
link to youtube.com
Woke means neo-Marxist.
So “Woke Corporations” advocate for their own destruction?
Does not seem very likely to me.
You understand so little Marty, but think so highly of yourself.
The epitome of Mount S___.
Always projecting those narcis sistic tendencies…
But I do agree; I’m the very pinnacle of evolution. PoE baby!
You are stuck on your VERY high Mount S.
What does “Neo-Marxist” mean? This is not an intuitively intelligible term. In particular, what is the difference between “Neo-” Marxists and ordinary old Marxists? If there is no difference, then 90% of the accusations of “woke”ness are obviously risible. If the “Neo-” imparts a distinction that makes those 90% accurate, what exactly is the signification imparted?
Greg, when ‘wingers use “woke” they mean Black, pro-caste system(s), and anti-regulation, of any kind.
When Libt ards use “woke” they mean non-white male, anti-caste system(s), and government regulation.
Actual Marxism? Ain’t been any of that around for literally decades, even in ostensibly communist countries. Its a complete anachronism.
When the right uses “woke” it is meant to reflect someone concerned about social justice above all else. When the left uses “woke” it is meant to reflect someone concerned about social justice above all else. It is defined the same by both sides. It is just that one side views it as an insult, and the other as a compliment.
Woke means “alert to injustice and discrimination in society, especially racism.” Per an online dictionary.
I wonder if people consider the derailment of the train carrying toxins in the white, republican-voting Ohio town of East Palastine environmental racism? Someone on the left tweeted that maybe they will change their voting patterns…
The takeaway from the derailment is that Buttigieg is incompetent and that the D party is so racist and partisan that they don’t care about areas of the country that don’t vote for them.
Watch the video or many others from academics about the Woke movement. Your definitions are pretty shallow. And within your definition is an assumption that the Woke policies will work.
You remind me of someone that said I don’t care about education because I am against the loan cancellation. That is the way of the Ds. If you oppose any policy of theirs on the grounds it won’t work, they say you are opposed to the goals.
Night Writer,
You alight upon the stick figure meme (style of XKCD) in which the Left stick figure pushes down the Middle stick figure who has made a valid observation of the Left, and then the Left stick figure screams out that the Middle stick figure is “Far Right.”
This is also akin to Malcolm’s L O N G habit of “one-bucketing” any one that disagrees with him into the same bucket.
I think you misread what I was saying. My definition is a very broad one. Purposely. I am not a woke supporter.
I agree that this Administration is showing a lack of concern for East Palestine. Because it is a mostly white, republican-voting community. So the MSM will not attack them for doing nothing.
Woke means “alert to injustice and discrimination in society, especially racism.” Per an online dictionary.
I admire the fact that—unlike many of our interlocutors—you are willing to provide an actual definition, instead of referring to a bevy of YouTube videos. I confess, however, that I am lost as to how that definition squares with the many complaints one reads of “woke corporations” or “woke politicians” (etc).
The job of (e.g.) Delta Airlines is to move passengers safely and quickly between various locations at a reasonable price. If Delta manages to do that, then why should it bother anyone if Delta is also “alert to injustice and discrimination in society”? Why should this bother anyone?
>>If Delta manages to do that, then why should it bother anyone if Delta is also “alert to injustice and discrimination in society”? Why should this bother anyone?
Your nonsense never ends. The issue is not “taking notice” but actions. The issue is not that injustices bother people but what to do about them. The core of communism probably isn’t bad but it just doesn’t work. The issue is authoritarianism and actions such as equity that demand equal percentages of people based on gender and race. The issue is censorship and corporations canceling people for not adopting the political views of the corporations.
And so forth. The fact is that Woke is diametrically opposed to the Constitution.
And at some point in your life you will probably wake up and realize that you have been brainwashed and are a coward.
The Woke want a society like China has where there are social credits, censorship, authoritarian rule, constant surveillance, and so forth. Wake up and read some of the articles in the NY Times or listen to what Gates is really saying.
The Woke are neo-Marxists. Take it upon yourself to figure it out. You are on the wrong side of history. You are on the side of monsters.
Your nonsense never ends.
Look, it is not my nonsense. It was PatentMom who cited that definition, not I. I was merely observing that if that definition were accurate, then all the complaints about “woke”ness would make no sense. I gather that we both agree that PatentMom’s cited definition does not accurately capture the meaning of “woke” as it is actually used.
The Woke want a society like China has where there are social credits, censorship, authoritarian rule, constant surveillance, and so forth.
So , here is the problem: you call me “woke” all the time, and yet I know with far more certainty than you could ever have that I do not want a society like China has where there are social credits, censorship, authoritarian rule, constant surveillance, and so forth. It follows necessarily that you are either wrong to call me “woke,” or wrong in your beliefs about what the “woke” want. One way or another, you are routinely proving that you do not know what you are talking about and should best be ignored.
Correction: they “make no sense” to Greg.
This is MORE a function that Greg refuses to understand (and wants NO ONE to understand) and far LESS a function of any “varying” meanings to the term itself.
.. and as far as Greg (personally) and “what he wants,” he attempts to ploy that ‘only one meaning applies, and he does not want ALL of that meaning, so the word must not mean anything” which of course is a fallacy.
Reminder: I have posited a spectrum of “followers” of Woke — based on an in-depth exposition of the same by Dr. Lindsay.
Greg whines about “bevy of YouTube” and then buries an internet link…
Night Writer, it would be helpful to keep in mind that Greg IS one of those monsters (‘on the side of’ is a understatement) as he purposefully obfuscates and attempts to diminish any viewpoint not aligned with his. He refuses to even consider facts that are not convenient.
Because making decisions on the basis of checking off boxes does not lead to fairness. It is discrimination. Nor does it lead to success for the corporations, and could actually have dire consequences.
Per whistleblowers, United has based pilot-hiring decisions on DEI. There have been several near catastrophes. One near Hawaii and one in Houston. Pilots should be hired on merit, not box-checking.
Do you need to be a biologist for checking boxes (not for corporations, but for certain legal institutions)…?
There too we have seen recent hiring decisions based on DEI
Greg, watch the video. Or try to read. There are literally thousands of videos many by full professors at Ivy League schools explaining the neo-Marxist movement in the USA.
The crux of it is that rather than social classes the neo-Marxist are using race and gender to try and force outcomes.
He won’t.
He (and others) also will not educate themselves with Dr. Lindsay’s dissertations (which are not only fact based, but delve into the very materials of the Liberal Left ‘thought leaders’ directly.
All you get for your troubles are people trying to dismiss the person and refusing to even bother with the content.
Great piece. Larger point is that these claims are indefinite, not ineligible. They should be invalid per se for using functional language at the point of novelty – you can’t have a claim to “a composition of X, Y, Z, wherein the composition works”. Unfortunately the CAFC is using its bad and amorphous 101 law to fix problems caused by its equally bad 112 law.
Another “belieber” is n the “point of novelty” canard (with the added twist of trying to cram this into 112)
And your “opinion” should matter why? And now for his Red Herring fallacy. Change the subject , Snowflake!
Ah, my pal Shifty jumps in, but what pray tell us a your point Shifty?
Goodness knows I do not want to stray and “change the subject,” so please tell me what – to you – IS ‘the subject?’
And by the way, to directly answer your question of, “And your “opinion” should matter why?” – at least a part of the answer is that I consistently have the last and best word between you and I. Granted, that’s a fairly low bar, so I would add that my contributions to on point law are among the top in this forum (and yes, this forum calls for a different style of discourse than formal legal channels).
Trying to figure out what a patentee added to the prior art is not a “canard”. It’s sort of important for resolving a patent case.
It looks a not so much the notion of what has been added to the prior art as it is the connotations of the term of art of point of novelty.
You appear to be using words without understanding – from terms of art to legal structure of law and rules.
…. let me guess, you are an examiner, eh?
This is really a bad opinion. The whole opinion rests on the CAFC comparing milk with the claims and determining there is no substantial difference.
That just doesn’t fly. If it is different, then it should be eligible under 101. Maybe it is invalid under 103 but that should be decided by the jury or an IPR.
See the problem is that the judges have subsumed 103 into 101. What they have done is say that a judge can look at a claim and if the judge feels there is no substantial difference between the claims invention and a naturally occurring substance, then the judges can invalidate the claims under 101.
Just ridiculously bad. The 1952 Act was crafted explicitly to avoid this type of opinion.
Correct — before 1952 the Court had run rampant with “Gist” (and numerous variants of the phrase), and 103 was explicitly added to the Statute — as extensively written about by the author of the 1952 Statute.
This is the Judicial Branch exceeding its authority.
On some level I agree with you that the 101 inquiry is too amorphous and inconsistent.
But if the only difference between the claimed invention and the prior art is the recitation of a natural law/abstract idea, then why do we care what provision we use to invalidate it?
A lot of these are “products but only those that work” claims that should fail at Rule 12 under 112 anyway.
We care because we understand the law as written by Congress.
The Ends do not justify the Means – especially in law.
Jay >>But if the only difference between the claimed invention and the prior art is the recitation of a natural law/abstract idea, then why do we care what provision we use to invalidate it?
The only difference is not just a “natural law/abstract idea”. There is a difference between the milk and the claimed invention. The judges are taking it upon themselves to contend the difference is minor and thus obvious. Not supposed to be part of a 101 analysis.
+1
The opinion does a nice job of claim element per milk component analysis. When the final claim element is not met by milk, that’s were the court errs. It uses 103, then 101 for the missing element. This is not how the law of 103 OR 101 works.
The putative “difference” between the claimed composition and natural milk is a process step (“isolated”). In other words, this is a product-by-process claim. U.S. law has long been that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985).
It would have been better if they had shot this one down on §102 grounds rather than §101 grounds, because that product-by-process analysis sits more easily in the §102 framework. This use of this product-by-process analysis in a §101 context is hardly new, however. See, In re Roslin Inst., 750 F.3d 1333 (Fed. Cir. 2014).
The word “isolated” is inserted to distinguish from the compound as found in nature. Before Myriad, this was routinely done to stay out of 101 land. After Myriad, it does not work. The claim is not, however, just to an isolated compound.
“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, … or polyanhydride,
wherein said composition is formulated for oral administration and increased NAD+ biosynthesis upon oral administration.”
If they had added the words “as a solid” before “for oral administration,” which is presumably how the supplements are formulated, i.e., as pills, tablets, etc., they would not have encompassed milk.
The word “isolated” is inserted to distinguish from the compound as found in nature.
I am sure that you are correct that the drafters intended “isolated” to distinguish from natural nictotinamide. However, this amounts to using a process limitation to distinguish a composition. Everyone knew—even at the time that they were drafting these claims—that this approach does not and cannot work under U.S. law. The Thorpe case was from 1985. It is a point well established by this day and age that the process steps do not get you any patentable weight in a product claim unless you can show that they result in a different product.
If I take some milk, isolate the nicotinamide, and then put the same nicotinamide back in, the milk is not discernibly changed at all. The claims, however, are broad enough to read on that circumstance. They are, therefore, broad enough to read on something that is identical to a natural product, even if that natural product has undergone a human manipulation (that leaves no discernible trace). Under Roslin, that is a distinction without a difference.
If they had added the words “as a solid” before “for oral administration,”… they would not have encompassed milk.
It would have still read on frozen milk. Frozen milk is just as much a product of nature as room temperature milk (in the history of the world, frozen milk has occurred without any human action).
Except, frozen milk will not be administered in that form.
Says who?
… perhaps the people doing the administering…
Goodness knows, if your milk is frozen solid, you are not likely in the context of the claim.
This is a excellent well-written article that gets everything right, including (most importantly) the take home message.
I thought the same thing. Good job by Mr. Duenckel.
Agreed. A well written contribution to the blog.
I have a comment waiting moderation. I don’t know why. Among other comments, I explain milk is not a suspension, but an emulsion.
Are emulsions and suspensions mutually exclusive categories? Is it impossible for a single substance to qualify as both?
The acid test for a “suspension” as opposed to a “solution” or “emulsion” is that the suspended particles in a suspension can be removed by microfiltration. Is it your contention that there is nothing in cow milk that can be removed by microfiltration? I assure you that there are components of cow milk that can be microfiltered out.
Direct from Wiki which would be confirmed by PHOSITA.
In chemistry, a suspension is a heterogeneous mixture of a fluid that contains solid particles sufficiently large for sedimentation. The particles may be visible to the naked eye, usually must be larger than one micrometer, and will eventually settle, although the mixture is only classified as a suspension when and while the particles have not settled out.
An emulsion is a mixture of two or more liquids that are normally immiscible (unmixable or unblendable) owing to liquid-liquid phase separation. Emulsions are part of a more general class of two-phase systems of matter called colloids. Although the terms colloid and emulsion are sometimes used interchangeably, emulsion should be used when both phases, dispersed and continuous, are liquids. In an emulsion, one liquid (the dispersed phase) is dispersed in the other (the continuous phase). Examples of emulsions include vinaigrettes, homogenized milk, liquid biomolecular condensates, and some cutting fluids for metal working.
1. Milk “comprises” a suspension. The problem with claim 3 (among others) is “the formulation” is without basis, so it doesnt say the NR has to be suspended.
2. Query also whether milk is food, and if you say it’s not, then yogurt, cheese, etc. will get you there (Might save you from the “naturally ocurring” 101 test, but at this point what are you trying to fight for?
3. How does milk in a tablet have “markedly different characteristics [from the natural phenomenon] and have the potential for significant utility” as compared to milk in liquid form?
1. Claim one recites “wherein said composition is formulated for oral administration.” The formulation in claim 3 has antecedent basis.
2. Milk is an emulsion (two immiscible liquids). Claim 3 calls for a suspension.
3. I don’ t believe this is the law. If this were applied across all chemicals, then no naturally occurring chemical, whether formulated into a pharmaceutical dosage form or purity, would pass this test.
Bottom line – none of these great discussions appear in the opinion!! The court waves its 101 hand and all these other important distinctions vanish!
But Malcolm is really happy, now isn’t he?
The “markedly different characteristics from the natural ocurring phenomneon” is the standard.
Otherwise, I could claim a “box comprising a naturally occurring product,” and it would be patent eligible, because the box does not occur in nature. (This is pretty much what claim 3 is– a “capsule” containing a naturally occurring product”). Milk in a carton is not patent eligible, neither is milk in a capsule.
Pharmaceutical patents get by this by better claiming (though some still fail). Dennis gave several examples of how that could have been accomplished here (minimum concentration of NR that set it apart from milk in a functional way would have done it).
The real issue with this claim is indefiniteness, not eligibility. In a better world, claim would be held per se indefinite at the Rule 12 stage for using functional language at the point of novelty–“combination of X, Y, Z but only the ones that work” is ridiculous.
But the CAFC’s indefiniteness case law is bad and excessively narrow, so we have to settle for CAFC’s badly expansive 101 law.
Kyle — in error here as well (by the way, the law of 35 USC is not EVER called a Rule, let alone Rule 12.
Rules are under 37 CFR
Snowflake, a lawyer would know that Rule 12 refers to the Federal Rules of Civil Procedure.
Well I stand corrected.
Mea culpa.
You’ve demonstrated yet again that you know nothing about US law and procedure. So again, your opinion should matter why?
Lol – hey, I admitted an error (in regards to prosecution — which is neither my forte, nor something I have delved in for more than seven years now).
What have you shown of yourself?
That is, other than your 0bsess10n with me, that you retired from your role at the patent office a few years ago, that is.
Rule 12 is “prosecution,” Snowflake? A lawyer would know that Rule 12 has nothing to do with prosecution, Snowflake.
Not prosecution in the sense of patent prosecution, but prosecution as in prosecuting a litigation matter.
That should be clear to you (yes, even you) in the context here.
Only a non-lawyer would try to cover up their ignorance with that nonsense.
You missed one, Snowflake. Must we alert your employer?
Back to your choice of old tricks?
Thank$$
And it is most decidedly odd to portray an admission of error as either nonsense or an attorney’s trick.
Why so much tinfoil from you?
Rule 12 is “prosecution,” Snowflake? A lawyer would know that Rule 12 has nothing to do with prosecution.
Asked and answered.
Thank$ for your choice of post.