by Dennis Crouch
In PureCircle USA Inc. v. SweeGen, Inc., No. 22-1946 (Fed. Cir. Jan. 2, 2024) (non-precedential) [PureCircle Decision], the Federal Circuit affirmed a district court summary judgment siding against the patentee, PureCircle. The court concluded that the stevia production method claims were all invalid, either for: (1) lack of written description for the genus claim or (2) lack of eligibility because the claims are directed to a natural phenomenon combined with an abstract idea. Judge Dyk authored the opinion of the court that was joined by Judges Schall and Stark affirming the ruling of C.D.Cal Judge James Selna.
The written description portion of the opinion parallels the Supreme Court’s 2023 Amgen decision that focused on the sibling doctrine of enablement. Although non-precedential, the eligibility portion appears important because of the way it combines prohibited eligibility categories and rules that method claims requiring a particular purity level are themselves an abstract idea absent requirement of specific steps on how that purity level is achieved.
PureCircle sued SweeGen for patent infringement back in 2018, asserting U.S. Patent Nos. 9,243,273 and 10,485,257. The patents here claim a method of making Rebaudioside X. Reb X is a steviol glycoside that occurs naturally in trace amounts in Stevia rebaudiana plants. It is considered one of the best-tasting steviol glycoside sweeteners, but extracting it directly from plants is costly and inefficient. PureCircle’s patents claim methods of producing Reb X by using certain enzymes to add glucose units to rebaudioside D (Reb D), another steviol glycoside occurring in higher amounts in Stevia plants.
Claims 1 and 14 of the 273 patent were treated as representative for the case:
1. A method for making Rebaudioside X comprising a step of converting Rebaudioside D to Rebaudioside X using a UDP-glucosyltransferase, wherein the conversion of Rebaudioside D to Rebaudioside X is at least about 50% complete.
14. The method of claim 1, wherein the UDPglucosyltransferase comprises UGT76G1.
As you can see, claim 1 broadly claims utilizing the functional class of UDP-glucosyltransferase enzymes to transform Reb D into the desired Reb X product at the specified yield. Narrower claim 14 eliminates the genus and instead requires a particular enzyme known as UGT76G1. This limitation appears to refer to a specific protein enzyme having a particular amino acide sequence.
Lack of Adequate Written Description
The written description requirement is rooted in 35 U.S.C. § 112(a) and requires a patent specification to demonstrate the inventor actually possessed the full scope of the claimed invention at the time of filing. As the Federal Circuit re-established in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), the test is whether the specification objectively “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. For genus claims that cover multiple embodiments, this generally requires disclosing either a representative number of species within the genus or common structural features shared by genus members, so that a skilled artisan can visualize or recognize the scope of species covered by the claims. Thus, under Ariad, purely functional claiming without correlation to defining structures risks running afoul of the written description requirement.
Here, claim 1 uses functional language to cover a genus of UGT enzymes capable of converting Reb D into Reb X. However, the patents disclosed only a single species – UGT76G1. PureCircle failed to demonstrate that this lone example was representative of the broad genus claimed. Nor did PureCircle establish that there were common structural features linking the members of the genus. The patentee made four particular arguments that were each rejected by the Federal Circuit:
- PureCircle argued that disclosure of a single enzyme species (UGT76G1) could be representative of the entire claimed genus based on prior cases like Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) and Bilstad v. Wakalopulos, 386 F.3d 1116 (Fed. Cir. 2004). However, the court held those cases require adequate “blaze marks” guiding a skilled artisan to visualize the genus, which were lacking here.
- PureCircle contended the structure of UGT76G1’s active site was common across the genus, but that commonality was not disclosed in the specification in a way that would permit PHOSITA “to visualize or recognize members of the genus.”
- PureCircle asserted that rather than trillions of enzymes covered by genus, homology modeling could narrow the genus down to around 9,000 variants. But the court noted testing so many candidates still indicated lack of adequate written description. And further, that homology modeling was not disclosed. In the language of Amgen, this was a “research assignment” rather than an invention disclosure.
- PureCircle invoked the original claims doctrine to argue those original claims provided support. In particular PureCircle noted that the claims found in the original PCT filing are part of the original disclosure even though later replaced by different claims. On appeal the court agreed with this legal principle but found those claims offered no substantive additional descriptive information beyond the issued claims.
As in other Federal Circuit decisions like AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014) and Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149 (Fed. Cir. 2019), PureCircle’s disclosure of a single UGT enzyme did not adequately describe the full scope of the genus claimed. “In short, the one enzyme disclosed in the patents here has not been shown to be typical of the entire genus of UGTs claimed.” Thus, the Federal Circuit affirmed the district court’s finding that the asserted patent claims lacked adequate written description support.
Claim 14 Directed to Patent-Ineligible Subject Matter in the combination of a natural phenomenon and an abstract idea.
The Federal Circuit then turned to analyzing the eligibility under § 101 of claim 14 of the ‘273 patent. This narrower claim specifically recited the UGT76G1 enzyme rather than the broader genus. The court held that “[t]o the extent that claim 14 claims a ‘method for making Rebaudioside X comprising a step of converting Rebaudioside D to Rebaudioside X using a UDPglucosyltransferase’ it claims a natural phenomenon.” The UGT76G1 enzyme occurs naturally in stevia plants and carries out such conversion in vivo.
Seeking to avoid ineligibility, PureCircle pointed to the requirement in claim 1 that “the conversion of Rebaudioside D to Rebaudioside X is at least about 50% complete.” Natural conversion achieves far lower levels. But the court held that “[t]he problem with PureCircle’s argument is that the 50% completion is itself an abstract idea.” According to the court, the claim merely demanded a result without any limitation on how to produce that result, running afoul of precedents like Interval
Licensing LLC v. AOL, Inc., 896 F.3d 1335 (Fed. Cir. 2018) where the court wrote that claims that “simply demand[] the production of a desired result . . . without any limitation on how to produce that result” are directed to an abstract idea.
Stan Panikowski of DLA Piper argued for the plaintiffs-appellants PureCircle. He was supported by attorneys Richard Mulloy of DLA Piper and Stuart Pollack of Kilpatrick Townsend. JC Rozendaal of Sterne Kessler argued for the defendants-appellees SweeGen. Supporting Mr. Rozendaal were attorneys Michael Joffre, Anna Phillips, Sasha Rao, Dennies Varughese, and Deirdre Wells, all of Sterne Kessler.
Surprised nobody in the case or the commentary here are pointing out that this is a single means claim which has been de facto invalid since 1983. See in re Hyatt, 708 F.2d 712. Although written description is proper it is also inherently a failure of enablement and I think its no great leap to call a claim to a function absent limitations nominating concrete means to achieve the function to be an abstract idea.
Love the federal circuit continually rediscovering the wheel though.
In the hands of the CAFC, Alice knows no bounds.
To them, SCOTUS’ 101 cabin has no door, no walls, no roof.
> According to the court, the claim merely demanded a result without any limitation on how to produce that result
As a step-plus-function claim, look for that in the spec??
This approach might save the claim if the patentee was interested in a claim limited to the specific reaction parameters recited in the specification and which are clearly those parameters intended to modify the recited step.
But, isn’t that what the patentee actually did here? Or is “step OF converting” different than “step FOR converting” in chemical land?
As a step-plus-function claim, look for that in the spec??
You can’t invoke 112(f) in a non-combination claim.
Once again, “abstract idea” in the singular being forced into a dual frame.
Claims aren’t inventions; they are symbolic representations of inventions.
Abstraction in a claim (patentability) is not the same as abstraction in an invention (eligibility) and until they are distinguished, it will remain a “know it when they see it” type of application.
“Abstraction in a claim (patentability) is not ALWAYS the same as abstraction in an invention (eligibility)”
Fixed for accuracy. I’ll also add that in the cases where the invention is arguably not abstract but the claim is absurdly broad and arguably eligible ONLY because of a recited desired result, the distinction is pedantic. That is the case here.
A claim that reads on a naturally occurring enzymatic reaction: ineligible.
A method claim identical to the above claim but reciting a desired result that is unbounded by ANY limitations on the method: ineligible, non-enabled, etc.
I think that’s reasonable.
To clarify/extend: abstraction in an invention should (must?) be intrinsic to the invention (something about the invention itself, e.g. its an item of logic or information) while abstraction in a claim arises from factors extrinsic to the invention (e.g. state of the art, PHOSITA’s understanding of the claim)…
But currently “abstract” is whatever a judge thinks it is, within or without the claim or invention.
“ currently “abstract” is whatever a judge thinks it is, within or without the claim or invention.”
I don’t think this is correct. I think in most cases both judges and attorneys are quite clear about the distinction between ineligible abstractions and ineligible non-abstractions (e.g., naturally occurring compositions or processes).
Then there are the cases pushing the envelope such as this (trying to patent a claim that recites a natural process by appending only an incredibly broad desired result to that process) where the claim offends on so many levels it’s hard to know when to stop trashing it.
“ quite clear about the distinction between ineligible abstractions and ineligible non-abstractions (e.g., naturally occurring compositions or processes).”
Go back and read Alice.
Please Pardon Potential re(Peat)…
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January 5, 2024 at 11:34 am
“ quite clear about the distinction between ineligible abstractions and ineligible non-abstractions (e.g., naturally occurring compositions or processes).”
Go back and read Alice.
“[t]o the extent that claim 14 claims a ‘method for making Rebaudioside X comprising a step of converting Rebaudioside D to Rebaudioside X using a UDPglucosyltransferase’ it claims a natural phenomenon.” The UGT76G1 enzyme occurs naturally in stevia plants and carries out such conversion in vivo.
Did the court address whether the natural phenomenon of the enzyme doing what the enzyme does converts at a rate of at least 50%? Or did the court just ignore this?
To be more clear, how did the court rationalize that the 50% conversion is an abstract idea? The rationale that is quoted in the write-up “the claim merely demanded a result without any limitation on how to produce that result” can be applied to any method of treatment claim.
A method of treating asthma in a patient comprising the steps of administering an effective amount of drug A [a corticosteroid].
Is this claim invalid as directed to an abstract idea because “the claim merely demanded a result without any limitation on how to produce that result?” Would I have to add steps in my method to the mechanism of action of the drug? For example:
A method of treating asthma in a patient comprising the steps of administering an effective amount of drug A [a corticosteroid];
wherein Drug A reverses the histone acetylation of activated inflammatory genes through binding of a liganded glucocorticoid receptors (GR) to coactivators, and induces recruitment of histone deacetylase-2 (HDAC2) to the activated transcription complex.
And what if we don’t know the mechanism of action, but we know the result? i.e., improves breathing in an asthmatic patient as measure by and air-volume test. Is this claim still abstract?
“ Is this claim invalid as directed to an abstract idea because “the claim merely demanded a result without any limitation on how to produce that result?””
Yes.
“Would I have to add steps in my method to the mechanism of action of the drug”
No, that would not work and would only highlight the problem with the claim. What’s missing (as has been already pointed out) are the limitations relating to the reaction conditions (temp, time, reaction components) that are needed to achieve the result.
This is not complicated. Also a reminder: in extreme cases the various parts of the patent act may overlap such that multiple sections of the act may be invoked to invalidate a claim (or render it ineligible). This is a feature not a bug.
How to I add “(temp, time, reaction components)” to a method of treatment claim? The claim already recites an effective amount?
What are the limits to the application of “abstract” by this court?
My apologies to the Assignee of this patent. US9878988. It was chosen at random.
Claim 30 reads “30. A method for blocking sodium channels in a human comprising administering to a human in need thereof an effective amount of the compound of claim 1, or a pharmaceutically acceptable salt thereof.”
Claim 1 is a novel compound. Is claim 30 abstract?
If the compound of claim 1 is novel and there is guidance in the specification as to what “effective amount” means (like a definition, or examples), then why would this dependent claim be categorized as “abstract”? What’s your argument?
Note that your hypothetical is a very different situation from the claims we are discussing here.
As noted above, the writing of the Alice case clearly indicates that claims THAT BOTH SIDES attested to as to being to actual physical structure were — nonetheless — DEEMED to be “Abstract.”
(even as the Court refrained from actually defining that word)
Even as Malcolm (incorrectly) states that you hypo is different, I have to chuckle as “per” the Macolm Singular Objective Structure Maximum Narrow And Easy To Design Around But Still Necessary Claim Writing protocol (MSOSMNAETDABSNCW), that “desired result” of “an effective amount” MUST also include in the claim ALL of the paremeters that MAKE IT to be an effective amount.
Given that this will vary NOT ONLY per individual, but also to numerous attributes WITHIN each individual, your proper MSOSMNAETDABSNCW claim will be quite lengthy (and exceedingly limited).
But that’s Malcolm for you.
(of course, I expect him to balk at being held to be consistent)
“converts at a rate of at least 50%”
There is nothing in the claim about “rates” so hopefully this was not addressed except maybe to point out that the absurdly broad claim has no limit on the time it takes to reach the desired result.
My apologies from my imprecision. The claim requires that the conversion of Rebaudioside D to Rebaudioside X is at least about 50% complete.
IN 5.1 you state: A claim that reads on a naturally occurring enzymatic reaction: ineligible.
Prof. Crouch stated the opposite in the article. “Natural conversion achieves far lower levels.” So this claim element, in my mind, is not naturally occurring and takes it away from 101.
What facts did the court use as evidence that a conversion of “at least 50%” is an abstract idea other than calling it so? I am agnostic to the outcome. What I am interested in knowing is the bounds of this rule the court made so I can apply it going forward (or stay away from it).
I tried to use a hypothetical claim to test the bounds. There was no direct response. Nothing in this write-up or comments on this board have clarified this ambiguity.
Read more carefully. There are two claims. The first claim reads on a naturally occurring process. That claim is ineligible. The second claim is an attempt to render the first claim eligible by adding a limitation. That CAN BE a successful approach but it obviously depends on the limitation. In this case, the additional limitation is nothing more than a fantastically broad desired result. A similar limitation could be “where the reaction converts the substrate to a level not observed in nature” or “where the reaction is initiated by a human.” This is self-serving verbiage that, if accepted, permits a claim drawn to ineligible subject matter to lift itself up by its bootstraps.
Friendly reminder again that this is just ONE problem with the claim and the other problems are arguably much worse.
“to lift itself up by its bootstraps”
B-b-but it’s a limitation…
Thanks for the response.
Can you also help me find he statute or regulation or even MPEP section that “a fantastically broad desired result” is a basis for a rejection?
My issue with the opinion is not the outcome. Its the rationale used to support the outcome. The court’s use of “abstract or natural result” for claim 14 is that the court’s analysis doesn’t support its conclusion. (see below which is a quote from the opinion.) The court’s analysis actually supports a 112 enablement rejection better than a rejection under Alice. Is a 50% conversion abstract? No. However, does the claim or specification describe how the enzyme achieves a 50% conversion as would be understood skilled in the art? Also NO.
“The claim does not provide any steps or give
guidance as to how to achieve a 50% conversion other than
the direction to use a natural enzyme. Claim 14 is directed
to subject matter that is a natural phenomenon or abstract
idea at step 1 of Alice/Mayo. 11”
My calls to Vital Records for Sarah W. McPherson are also being denied, and blocked as before. I no longer in chains. So why does GOOGLE continue to block my Federal Rights?
“a step of converting Rebaudioside D to Rebaudioside X using UGT761 wherein the conversion of Rebaudioside D to Rebaudioside X is at least about 50% complete”
Given that this “conversion” is one of the recited enzyme’s natural activities, listing a desired “state of completion” adds nothing without some limitations on reaction conditions (temp, timing, reaction components). The method isn’t even limited to an “in vitro” reaction!
Not so.
Unless perhaps you think that the natural activities — given SOME natural reaction conditions — might generate the objective physical structure of the claimed composition having the “at least about 50% complete conversion” having happened.
There is NO such requirement – especially given your predilections – with the claim element to have the “how” when the “what” is provided.
If a claim includes an element of using a hammer, there is no requirement specifying the “how” the created.
“ Unless perhaps you think that the natural activities — given SOME natural reaction conditions — might generate the objective physical structure of the claimed composition having the “at least about 50% complete conversion” having happened.”
Might? That’s 100% certain if I’m unconstrained by any parameters. In some plant cell or vasculature right now there is surely a space in which, within that space, the enzyme has converted more than 50% of the substrate. I’ll say it again: it’s a meaningless limitation in the context of that claim.
“Might? That’s 100% certain if I’m unconstrained by any parameters.”
The constraint — quite obviously — is that it must be parameters as would occur in nature.
Try again.
The “parameters” I described do occur in nature.
Reminder: this claim recites ZERO parameters other than a result. It’s unbounded by time, concentration, volume, mass, temperature, or the existence of any other components. That leaves me with a lot of leeway.
Try again – this time WITH the constraint in mind (and GIVEN the facts presented that IN NATURE – regardless of constraints, the limitation is NOT to be found).
The fact that it may be “unbounded” does NOT mean that the item IS found in nature, given the fact that nature CANNOT provide the “desired result.”
You may want to try a different argument, as the Means to an End do matter, and your Means here don’t make it.
Again: as written, the stated conversion level in the claim is certainly found in nature because the stated conversion in the claim is that absurdly broad. If you can’t understand this, too bad. Open a textbook and teach yourself about enzymes and molecules. They are very small! Like your mind.
“Again: as written, the stated conversion level in the claim is certainly found in nature”
AGAIN – no, no it is not. This is a GIVEN in this context.
Maybe instead on being so intent to your statement, you actually read the facts as presented. That way your insu1ts of “small mind” do not boomerang and stick to you (as usual).
My answer is in the holding tank.
Sadly, it made it out of the holding tank.
Why is every time someone makes a comment about your inabilities you comment on every single post, as if you can override what is stated. What is wrong with you? Maybe you need meds anon.
My what lovely glass shards of a former house you have.
What are you implying anon? I don’t care. Argue with those you think are … on your cognitive level GHAGHAGHA. Surely I am not on meds and don’t qualify.
Is not the claim element a composition-related phrase?
That is, certainly there is an objective physical difference between the composition of nature and the claimed composition having the “at least about 50% complete conversion” having happened.
If you had been paying careful attention, you would have noticed that it was a method claim–not a composition claim, but don’t let that stop you.
If you had been paying careful attention, you would have noticed that he used the phrase “claim element a composition-related phrase.” Method claims nearly always include physical elements (e.g., machines or compositions) as part of the claim language.
No worries Wt – I am quite used to the fact that the mere litigator NS II most always jumps into conversations on the wr0ng side of the fence.
Moments like this NS II, in which your eagerness to jump results in your stunned silence that are SOOOO enjoyable.
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