As part of my patent law class every year I hold a moot court competition. This year we are doing a mock-appeal based upon Judge Huff’s decision in Natural Alternatives International, Inc. v. Creative Compounds, LLC, 2017 WL 3877808 (S.D. Cal. Sept 5, 2017) [case file link].
In her decision, Judge Huff granted Plaintiffs Rule 12(c) motions for judgment on the pleadings – ruling that all claims of the five asserted patents were invalid for claiming ineligible subject matter under 35 U.S.C. § 101.
A few of the claims at issue:
34. A human dietary supplement for increasing human muscle tissue strength comprising
a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide,
wherein the human dietary supplement does not contain a free amino acid L-histidine,
wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose,
wherein the amount increases the muscle tissue strength in the human, and
wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.
Claim 34 of the U.S. Patent No. RE45,947.
6. A composition, comprising:
glycine; and
a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or
b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide;
wherein the composition is a dietary supplement or a sports drink; and
wherein the dietary supplement or sports drink is a supplement for humans.
Claim 6 of U.S. Patent No. 7,504,376 (Note, claim 6 is a dependent claim, and I have reformulated it in independent form by incorporating elements of the parent claims).
1. A method of increasing anaerobic working capacity in a human subject, the method comprising:
a) providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:
i) beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;
ii) an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or
iii) an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and
b) exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue,
wherein the amino acid is provided through a dietary supplement.
Claim 1 of U.S. Patent No. 8,470,865.
Important in her decision is that the approach to eligibility of products-of-nature is: Myriad in light of Mayo. How would you argue this case?
In the world of super supplements, there can be only one outstanding winner. It just hast to be “Diane’s Manna” (she should have changed her name to Dianna, by the way).
US-8,609,158
link to patft.uspto.gov
1. A method of treating a human suffering from cancer, pain, and Bipolar disorder consisting essentially of administering to said human therapeutically effective amounts of evening primrose oil, rice, sesame seeds, green beans, coffee, meat, cheese, milk, green tea extract, evening primrose seeds, and wine.
A claim that only the most ill of patients could ever infringe, provided by the helpful examiner.
The spec is worth skimming for fun in a down moment, too.
P.S. Thank you for sending the comment formerly known as 10 to its just desserts.
Chicken soup and a ham on rye and you’re half way there.
Caputo, 55, said he along with a group of small-business innovators will lead an unauthorized protest on Friday afternoon outside the United States Patent and Trademark Office in Alexandria, Va.
Caputo said continuing the previous administration’s patent policies — which he and many small-business innovators have argued favor large corporate entities such as those in Silicon Valley — would contradict Trump’s “personal beliefs” as well as his campaign promise to promote small-business innovation.
…
Caputo runs a public relations firm. He resigned from the Trump campaign last summer amid a dispute with then-campaign manager Corey Lewandowski.
It’s a good bet that Caputo is going to go down with the rest of these s c u m bags. And that will be a delicious moment.
Thank goodness the linkages between these crooked Re p u k k k e li z ard br@ ins and the patent maximalists are sooooooooo hard to identify.
“and the patent maximalists”
You are doing that “one bucket” thing again Malcolm.
What next? A reversion back to your old Silence of the Lambs “Buffalo Bill” style of writing?
Do not use 102 and 103 analyses under 101 and you’ll almost surely come up with the correct answers AND REASONING, even in view of the judicially created exceptions to subject matter eligibility.
Claim 34 boiled down to reality: a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide,
wherein the [mixture] does not contain a free amino acid L-histidine,
wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose,
This has a shot at eligibility if it doesn’t read on anything naturally occurring. All the money rests on this phrase, I think: free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide.
The more glaring issue for this claim is not eligibility but obviousness and definiteness. That dosage limitation is meaningless or ridiculously broad as far as I can tell. What’s non-obvious in 2017 about a composition comprising amino acids, where the amino acids aren’t even limited by their relative ratios to each other or anything else?
The reissue claim, boiled down:
6. A composition, comprising:
glycine; and
beta-alanine
wherein the composition is a dietary supplement or sports drink
LOL
What is the super awesome definition of “dietary supplement” I wonder? I’m sure it’s very very limiting.
As for this: wherein the … sports drink is a supplement for humans.
… double LOL … in contrast to the sports drinks for cats and gerbils?
I said it before Myriad and I’ll say it again: subject matter eligibility comes in many different flavors. By far the flavor that needs to be dealt with most sensitively is the category of novel non-obvious structurally distinguished composition of matter claims.
Myriad’s claims could easily have been dealt with using utility or 103 or even 112 (and savor the irony of the patent maximalists who couldn’t figure that out but who otherwise never quit with the “103/112 can do it” script even when the wrongness of that script is painfully … obvious). Instead Thomas wrote an expressly narrow decision — almost impossibly narrow to the skilled reader (i.e., someone who knows what the term “cDNA” encompasses, who understands how the so-called “genetic code” works, and who understands that “DNA sequence” and “DNA structure” are the same thing to your average gene jockey and or genetic diagnostician). And that opened the door to some weirdness, as many (like me) predicted would happen.
With respect to these particular claims, let’s get one thing straight: the field of “dietary supplements” is a playground for charlatans and always has been. The term “snake oil” is old for a reason. And the modern day version of “snake oil”, without any doubt, is the “sports drink” and it’s solidified companion the “energy bar.” Of course the charlatans run to the patent office with their “recipes” and usually the running begins right after a third party (typically academic) publishes a research paper suggesting that “X prevents Y” or “X increases Y”. Time to add some X to the magical concoction! And someone tell the folks in advertising to start the campaign.
Second, the way to approach these kinds of claims if you’re looking for a way to tank them is to cut past all the verbiage and read the claim for what it claims. THat means picking the broadest alternatives among the listed alternatives. Note that this isn’t “BRM”. This is just plain reasonable. It’s what the law requires.
Claim 6 is probably the cr @ppiest on its face. Broken down and setting aside the functional/result language and leaving just one “alternative” “formulation” it reduces to this:
A method …comprising:
a) providing to the human subject an amount of an amino acid … wherein said amino acid is …
i) beta-alanine
wherein the amino acid is provided through a dietary supplement.
I could have dropped out the “dietary supplement” language because it’s utterly meaningless but I left it in for laughs. (did I check the spec? no — but go ahead and surprise me with a super narrow definition of “dietary supplement”).
What your looking at is ancient anticipated cr @p. The eligiblity problem can arise from this starting point in at least two major ways. First, you could recite the above method and then add a step of, e.g., “thinking about the World Series”. That’s an ineligible claim for reasons that aren’t worth going into (if you can’t follow this far then you need to call your insurance provider). Second, you could recite a “natural phenomenon” that flows from the steps in the prior art, i.e., “wherein X is increased in tissue”. That’s what’s going on here. The circular limitation about “adding the amount effective to increase X in tissue” adds nothing. And the ba l0ney in the preamble about “increasing muscle mass” is just an intended result. Worthless. Note that there is nothing in the body of claim requiring that muscle mass is increased by any clear and substantial amount. Gee, I wonder why that is?
Now I will let the chicken littles run with this for a bit. But here’s how the story ends: this kind of analysis of method claims does not mean that “drugs aren’t patentable” or even that “methods of treatment aren’t patentable.”
“By far the flavor that needs to be dealt with most sensitively is the category of novel non-obvious structurally distinguished composition of matter claims.”
Why the sensitivity?
(no snark)
“By far the flavor that needs to be dealt with most sensitively is the category of novel non-obvious structurally distinguished composition of matter claims.”
Why the sensitivity?
Because there’s no scrivening involved. There’s no hiding the ball or attempting to capture ineligible subject matter by limiting it to a prior art context. The claimed composition in the situation I’m referring to is new and non-obvious and properly claimed (i.e., distinguished from the prior art and nature on the basis of its objective physical structure). In case you missed, as claimed the composition I’m referring to is not a product of nature. Any “test” that ventures across this line (eating into well-claimed new non-obvious non-natural products) has to be extremely specific and limited in what it blocks or it will eat up other well-claimed non-obvious compositions. That’s why Thomas’ opinion made sure to distinguish between “isolated DNA” and “isolated cDNA” (one of the few points of clarity). The problem is that it didn’t spend enough time clearly dealing with the underlying theory of the holding or the issues that leap immediately into the skilled artisans mind like … “isolated” proteins that turn out to be subsequences of naturally occurring proteins.
And before you try to float some argument that this is situation is no diffferent than claiming ineligible logic performed by a programmable computer that exists for the sole purpose of carrying out logic, please check yourself because you couldn’t be more wrong.
“Because there’s no scrivening involved.”
That is simply not true.
There is ALWAYS scrivening involved.
“there’s no hiding the ball or attempting to capture ineligible subject matter…,”
Well, given how misplaced your feelings are to ineligible subject matter, a reply on that topic will not register with you. But as to “hiding the ball,” there too we are really only dealing with your feelings, aren’t we?
“and properly claimed”
Still at your old tricks of trying to elevate one optional claim format into something other than optional? Your use of “proper” is NOT proper. And yes, we both know this.
“that this is situation is no diffferent than claiming ineligible logic performed by a programmable computer that exists for the sole purpose of carrying out logic,”
I am not the one that needs to “check himself” on this topic – that would be you. Six ways to Sunday you continue to prevaricate and mislead as to “logic” and “sole purpose” and all of your other trite scripted items, while the plain facts of the matter are items that you refuse to treat or acknowledge with ANY sense of inte11ectual honesty (even after being burned by volunteering an admission against your interests as to knowing and understanding controlling law when it comes to the exceptions to the judicial doctrine of printed matter.
Your use of “proper” is NOT proper.
Of course it is. We’ve had multiple threads on this topic and there’s no serious disagreement about it. There’s just you whining and playing semantic games. The CAFC knows the score. Why don’t you? Answer: because your clients will sue you once they realize what you’ve done.
It is NOT proper because you are expressly trying to make an optional claim format into a NON-optional claim format.
There is simply no “agreement” with you on this point – serious or otherwise.
There is no “whining” from me on this.
There is no playing semantic games from me on this.
Do you simply not understand what the meaning of the word “optional” is?
Or do you really think that your mere bland repetition will somehow change that meaning?
100% chance this decision is reversed by the Federal Circuit.
I guess that is what makes it an interesting moot court argument.
100% chance this decision is reversed by the Federal Circuit.
Don’t bet on it.
Do we know who’s on the panel?
PYT with the question of the day!
(followed by, why IS it that the CAFC is so panel dependent?)
I understand that 101 is purely a question of law, but in this case, we need the help of experts. How do you find an inventive concept in a composition of matter? Does it glow in the dark? Does it precipitate with juice of routine?
Myriad in view of Mayo: now the test for eligibility is that the claims must recite an applied transformation of an inventive concept markedly different from a conventional element not found in nature. More to come in Bilski in view to Alice and Myriad…
Sorry PiKa, your paraphrase is NOT correct:
“from a conventional element not found in nature.”
“in nature” has already been “gisted” away by the Court (see post 1.1 below)
Pika, come on. All the claims have to do is recite a new or improved “manufacture.”
Ned,
As has been amply pointed out to you, the Supreme Court in Alice held otherwise.
This is not the first time you advance what is clearly not so in this exact regard.
Anon, ? What are you smoking? A claim to a new or improved manufacture was held to violate 101 in Alice?
Absolutely.
Some of the claims stipulated by both sides in Alice as meeting the statutory category were none the less deemed “directed to,” and thus being, “abstract.”
Since when does the Court get to decide for itself that the statutory categories are meaningless?
Oh yes, since their fingers in the wax nose of 101 addiction.
anon, then it was not a claim to a new or improved manufacture but to a principle in the abstract. What was a manufacture was neither new nor improved.
No Ned – your Windmill is not located here. The claims were to a “new or improved manufacture” – just as has been pointed out to you from the beginning.
This merely shows that the “Gist/Abstract” sword can be swung at anything.
Which is kind of the point of the uproar and kind of the point that people are saying that the scoreboard is broken.
Ned, I was just having fun with the combinations you can create by mixing together holdings from different opinions without considering the differences between facts underlying the opinions.
Pika, thanks. However, there are “holdings” and then there are what the Supreme Court said they held. Whose opinion counts?
The opinions of the Supreme Court count. But, the opinions of the the Supreme Court have considered claims to a composition of matter separately from the claims to a method or to a machine. In theses opinions, the Court has developed a “markedly different” standard. I am not aware of any Supreme Court opinion holding that you need to find an “inventive concept” in a composition of matter, as suggested in the Myriad in light of Mayo reasoning that you find in Judge Huff’s opinion. Imagining an alchemist trying to find an “inventive concept” in a composition of matter made me smile. That’s all.
Pika, inventive concept? What the courts are looking for is an inventive application: translation, a new or improved “manufacture.” This has nothing to do with inventive step.
The problem most people have is the use of “inventive” in the terminology, which suggests a 103 inquiry. That is what confuses. But all you have to look at is the holdings themselves — all the way back to Nielson, to see what they are looking for.
Are we discussing Judge Huff’s opinion, a Supreme Court opinion, or your opinion? My point was only that Judge Huff is looking for an “inventive concept” somewhere in a claim describing a composition of matter. That is what amuses me.
A litigator friend of mine just told me that “inventive concept” is easy to detect, thanks to its property of turning into gold in the presence of felix felicis. The rumor had it that a large deposit of felix felicis was found in Tyler, TX.
I love it!
This seems, from the District Court decision, to be what that court found the most persuasive argument?
“Even if the patents-in-suit relate to achieving an unnaturally high level of carnosine synthesis, the relationship between beta- alanine supplements in one’s diet and the achievement of an unnaturally high level of carnosine synthesis is still a natural process that exists in principle apart from any human action and, thus, is a natural law.”
[But, was that a KNOWN relationship?]
One thing that could be argued that might distinguish the composition claims from Myriad is that the claim as a whole in Myrid was substantially directed to a product of nature, a single, isolated gene, whereas the claims here are directed to a mixture of isolated amino acids. The isolated amino acids themselves do substantially occur in nature like the isolated gene in myriad. However, this particular mixture , in its entirety does not occur in nature.
What is the relevance of the Mayo decision to these claims though?
Quasar18,
How do you feel about Funk Brothers?
Is that case still good law?
I know it is pre-1952.
My view on 101 is that 103 type combination logic shouldn’t be used. Either a claim is directed to a product of nature or it isn’t and you have to look at the claim as a whole.
The burden shouldn’t be on the patentee to determine that either.
So I think funk brothers ideally shouldn’t be good law.
BUT combining products of nature with known properties should be obvious under 103.
Well Funk – being pre-1952 – technically cannot deal with either 101 or 103 because the Act of 1952 carved up the prior single paragaph and changed the meaning of the words that went into 101 from that single paragraph.
This is the history lesson that I have been trying to teach Ned (also part of that lesson is the expansion involved in both “process” being formally recognized as not merely a handmaiden of the hard goods categories with the change of definition of 35 USC 100; and also tangentially related is the expansion of use of terms of function – quite outside of what is now 112(f) – outside of the “single means” types of claims).
As to combining products of nature with known properties – this is NOT a de facto obvious finding under 103 because 103 is not a mere “more than one art reference” version of 102.
Thus, “should” is not correct. The proper term is “may.”
You have to take a look at how Chakrabarty dealt with Funk Brothers. The bacteria in Funk Brothers was unmodified and therefore was not new manufacture. The bacteria in Chakrabarty was modified and therefore was a new manufacture.
“ The bacteria in Funk Brothers was unmodified and therefore was not new manufacture. ”
This just rings of the “The protons, neutrons and electrons were unmodified and therefor was not a new manufacture” line of “logic.”
Nobody in Funk Bros. was claiming a bacterium. The claims were to a mixture of bacteria, and the mixture was new and improved relative to prior mixtures (both mixtures in nature and human-made mixtures).
Justice Frankfurter’s concurrence got Funk Bros. exactly right. As usual, the Court’s opinion really could not have been more wrong.
Greg and I are in agreement.
(the underlying note here is that perhaps Greg rejects the fallacy that others engage and which is captured in the Big Box of Protons, Neutrons, and Electrons theme)
Greg rejects the fallacy… captured in the Big Box of Protons, Neutrons, and Electrons theme…
Definitely!
Greg, and the reason why the Funk Bros. claims failed and the Chakrabarty claims did not fail 101, as explained by the Supreme Court itself, was…….?
… unintelligible but self-serving logorrhea to disguise past mistakes.
His claim is 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] 310*310 use.” Hartranft v. Wiegmann, 121 U. S. 609, 615 (1887). The point is underscored dramatically by comparison of the invention here with that in Funk. There, the patentee had discovered that there existed in nature certain species of root-nodule bacteria which did not exert a mutually inhibitive effect on each other. He used that discovery to produce a mixed culture capable of inoculating the seeds of leguminous plants. Concluding that the patentee had discovered “only some of the handiwork of nature,” the Court ruled the product nonpatentable:
“Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.” 333 U. S., at 131.
Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.
Ned,
Use your very same “logic” but instead of species of legumes use the even more basic Proton, Neutron, and Electron.
Let me know how this works for you.
Demurrer. Assuming that all of the allegations are true, the plaintiff has failed to state a claim as a matter of law. Tough burden.
All of those various chemicals are made up of conventional atomic elements. The rest is just insignificant post-solution hand waving. If you patent maximalists were sooper serious, you’d admit this.
That sounds very much like the sooper serious Big Box of Protons, Neutrons, and Electrons.
As to the case itself, the “Myriad in Light of Mayo” goes BEYOND the instant judge’s noting of the byproduct itself being a natural substance as some type of limitation to the 101 sword.
Whether or not the byproduct is itself a natural substance is outside of the Supreme Court reasoning.
Once that “seeming” limitation is removed, the actual logic applied here implicates that ALL pharma patents that rely on the use of the human body to metabolize any claimed (ingested or otherwise delivered) drug are to be deemed “ineligible.”
Once again I am reminded of the WWII film clip spoof, and the point in the spoof in which one woman consoles another in the hallway as the crowd listens to the rant of the German leader: “Don’t worry, business methods are not products of nature”
If your (Pharma) claim is “directed to” a product of nature, or even a law of nature [being, that a human body will metabolize items supplied to the body] – and tell me of any Pharma claims this is not so “directed” – the Court has swallowed the actual words of Congress, and the statutory categories themselves have become meaningless.
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