by Dennis Crouch
Prof. Chris Holman recently characterized Amgen v. Sanofi as an “endorsement of the Federal Circuit’s current interpretation and application of the enablement requirement, and maintenance of the status quo.” Although I largely align with Holman’s views, I note that the Supreme Court did not explicitly engage with Federal Circuit precedent. More specifically, the Court neither cited nor discussed any Federal Circuit or CCPA decision outside of case-specific historical documents.
The most recent enablement case invoked by the Supreme Court in Amgen is Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928). The Court also referenced several other historically significant enablement cases, including Wood v. Underhill, 5 How. 1 (1846); The Incandescent Lamp Patent, 159 U. S. 465 (1895); and Minerals Separation, Ltd. v. Hyde, 242 U. S. 261 (1916). The Court went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision. The approach of Amgen echoes that of the Supreme Court’s 2010 Bilski decision, which advised a simple adherence to established precedents. The only non-Supreme Court decision that Amgen cites is Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813). Notably, Whittemore was adjudicated by Supreme Court Justice Joseph Story while on circuit duty.
In looking at the leading Supreme Court precedent case of Holland Furniture, it is telling that the Federal Circuit has invoked this case only twice – in both instances, for discussions regarding means-plus-function claim interpretation, not enablement. Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species, as well as (b) genus claims that encompass inoperable species. The case involved a patent covering starch-based glue. The Supreme Court explained “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions, or even all starch glues made with three parts of water and alkali, since starch glues may be made with three parts of water and alkali that do not have those properties.” Id. The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.
Elephants in the Room: The Federal Circuit has adjudicated numerous biotech enablement cases, providing nuanced analysis, none of which was cited or dissected by the Supreme Court. Perhaps the simply have a tit-for-tat since the Federal Circuit so rarely cites the Supreme Court in enablement cases. The appellate court’s Amgen decision, for instance, cited many Federal Circuit opinions, but nothing from the Supreme Court. In many ways, the two courts are simply talking past one another without disagreeing.
A critical case absent from the Supreme Court’s Amgen analysis is In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In Wands, the Federal Circuit introduced a set of factual considerations to assess whether a claim is sufficiently enabled or would necessitate undue experimentation – a key factor is the amount of experimentation required. In Amgen, these elements were handed to the jury for adjudication as mandated by the 7th Amendment. The jury in Amgen sided with the patentee, deeming the claims enabled. However, this pro-patentee verdict was overturned by the district court on JMOL, a decision subsequently affirmed by both the Federal Circuit and the Supreme Court. In its deliberation, the Supreme Court seems to reassess the Wands factors de novo without acknowledging the jury’s verdict. Intriguingly, the Supreme Court’s opinion finds substantial experimentation necessary, but does not even acknowledge the existence of a jury verdict, simply stating that “both the district court and Federal Circuit sided with Sanofi.” This omission marks a significant oversight by the Court.
While the Supreme Court’s decision in Amgen v. Sanofi seems to generally affirm the current approach of the Federal Circuit to enablement, it lacks any depth of engagement with the nuanced analysis often conducted by the Federal Circuit. In particular, the absence of reference to In re Wands and its eight-factor test, is a surprising omission. Even more disconcerting is the Court’s disregard for the jury’s verdict in the original Amgen trial, reflecting a potential underappreciation of the complexities of patent law and the factual determinations involved. It remains to be seen how this lack of engagement with Federal Circuit precedent may influence future patent law decisions. Most likely, the Federal Circuit will continue its historic approach implicitly suggested by Prof Holman and continue to ignore the Supreme Court precedent on point.
I’ll say it again. Under current 35 U.S.C. 101 case law, information processing machines that can do the job of CAFC judge are ineligible or can easily be held to be ineligible.
And “The Prophet” since you think the level of skill in A.I. programs is as easy as playing bingo, can you explain to us in a paragraph how modern A.I. programs work? I didn’t think so. I am sure you will respond with libelous statements against me.
Again, A.I. has attracted some of the most intelligent people and most educated people in the world. In my practice, often the inventors have advanced degrees in math/information processing.
Just think about that. A machine that can do the information processing job of a human is ineligible as being “abstract.” And Covid didn’t come from the Wuhan lab. The Biden laptop is fake. And so forth.
The CAFC is already of the opinion that AI is generic
I have heard that any notion of AI (or machine learning or other like technical effects) will be treated as to being the equivalent of “and do it on a computer” (does not add “significantly more”) by certain examining units (regardless of any 2019 PEG directives or other controlling memorandum).
The trouble with “AI” is that there’s nothing of “intelligence” about these processing systems. They’re well-designed combinations of algorithmic and non-algorithmic processing, but every “AI” system (ironically) can be done by a person with a pencil and paper.
“can be done by a person with a pencil and paper”
That would be false, given the inputs and timed outputs.
Let’s put that “pencil and paper” trope where it belongs: in the gar. bag€ bin.
Most of these predictive algorithms have no timed data
The whole pencil and paper trope is lame beyond belief – my point, however, was to show that “AI” is merely computer algorithms same as all the rest.
Well, under that case law and the Church-Turing Thesis, all information processing methods are ineligible.
Sure, that is the Church-Turing Thesis.
The level of skill in the “do it on a computer” “arts” is equal to the level of skill in the “bingo game management” “arts”. This is important because it puts a high burden on the Examiner when making an enablement rejection. Or maybe it’s a low burden.
In any case, it’s a whole different story when we’re talking about sorting parcels of real estate, weather using a computer or not.
Discuss.
Whether is the operative word. Spell much?RICHARD C. LITMAN not lotman.
Your denigrations do NOT make the point that you think them to do.
All your whining does is show your feelings are askew to the fifth (and most likely sixth) Kondratiev waves of innovation.
How much for that denial?
One of the Wands factors is the level of ordinary skill (or the relative skill in the art as stated in the case itself).
link to uspto.gov
I have beaten back the Examiner in 112 rejections where I pointed out they failed to determine the level of ordinary skill in the art. And when I say “beaten back”, I mean they withdrew the 112 rejection in the next Office Action.
I’m doing a study on 112 examination – I’d love to see examples if you can send it to me.
Most are actually pretty simple. I quote the MPEP, and lay out the Wands factors, and tell the Examiner they failed to provide any analysis for one or more of the factors.
If I find something more than basic, I’ll be happy to send it to you.
Maybe as part of your study, Dennis, investigate which “arts” include the most instances of Examiners withdrawing 112 rejections because the applicant challenges the Examiner about the “level of skill in the art.”
LOL — in advance of your surprising discovery LOL
You seem to be thinking that your rants are revealing some high-brow point (and one that fits your oh-so-wise narrative).
They do not — you have no such narrative.
All you have is disdain for a particular type of innovation, and an extreme level of cognitive dissonance of your being in a profession that generates legal rights of a personal property nature.
I haven’t seen an Examiner address the Wands factors in years. Most don’t seem to understand 112 enablement is evidence heavy.
I was (attempting to) teaching MaxDrei on a prior discussion as to why the Office has a difficult time with 112 rejections (correcting several examiners as well who claimed ‘the Office wouldn’t let them do it’).
Case law dictates the burden on the examiners, and as you mention, it is a case that requires facts to be presented as well as clear logic.
They don’t make “form paragraphs” for that.
+1
What “art” are you talking about? I’ll go waaaaay out on a limb and guess it’s not biotech.
The bigger issue is that it’s not the level of skill of the artisan that matters. It’s the level of b.s. that the patent office is willing to endure from the applicants in that field that matters. And we know that in the computing arts the level of b.s. is extraordinarily high because the field not only tolerates a high level of b.s. but requires it.
As always Malcolm, feel free to abstain from any Art type of innovation that you would deign to deny innovation protection to.
“the level of b.s. is extraordinarily high because the field not only tolerates a high level of b.s. but requires it.”
Actually, it’s more Ph.D level. A B.S. just doesn’t cut it.
Let’s put it this way: how do you believe the “level of the skill in the art” affects the arguments that PTO is permitted to make about enablement and/or the evidence that the PTO is allowed to present? Also, what questions need to be answered in order to determine the level of skill in “the” “art”?
Because you seem to believe you are being serious when you demand that the level be shown, presumably you have answers. Right? LOL. The floor is yours.
When answering these questions, also address whether it matters if the named inventor is an attorney by profession who has never been employed in the field in question or who has a minimal technical degree (a bachelor’s degree) with no substantial work experience in “the” “art”.
Shorter Malcolm: “you need ze papers to innovate.”
“Because you seem to believe you are being serious when you demand that the level be shown”
What are you ranting about now?
ipguy “ I have beaten back the Examiner in 112 rejections where I pointed out they failed to determine the level of ordinary skill in the art.”
I’d like to see a single example of this because the more I think about it the funnier it is. Except for the malpractice aspect of it although that’s actually funny too given the author of the comment.
Meh, I have no reason to doubt the capability of ipguy from the content of his posts.
YOU on the other hand prove your lack of capability with your incessant anti-patent apoplectic rants.
+3
” The Court went to lengths to present O’Reilly v. Morse, 15 How. 62 (1854), as an enablement decision, even though in both Alice and Mayo, the court had labeled O’Reilly as an eligibility decision.”
You saw that same thing in the Killian v. Vidal petition.
Yet another cert-drone attack on the Supreme Court’s 2014 and prior “unpatentable subject matter” decisions was just denied in Avery Dennison Corp and ADASA Inc,. re a patent on tracking tags that was held to be patentable subject matter below. [Does that sends this particular case back to the D.C. for 103 reconsideration?]
P.S. Not entirely OT, since this is an even bigger Sup. Ct. “non-engagement” on a patent law hot topic
“Does that sends this particular case back to the D.C. for 103 reconsideration?”
I think so, and the lurking 102/103 issues may be the reason for denying cert … ? Not that I agree with the 101 decision by the CAFC (Moore, Hughes, Stark, for those keeping track).
I’ll say it again. The key is scope of enablement which must include all that every person skilled in the art knows and probably should be wider than that and include POSITA knows.
The key is the reverse doctrine of equivalence that if someone invents something that is non-obvious within your claim scope, then you can lose your claims.
It is really pretty simple.
It does seem like there is a slight variation of this where the claim scope includes some method that someone else has to perform to figure out part of the invention and the issue is how complicated can that method be. I am still thinking about Amgen v. Sanofi. Haven’t completely decided.
Can you write more, because what you have so far written reminds me of the retort made by an English judge (when it was pleaded before him that the embodiment accused of infringement was inventive, and so could not be an infringement) that adding invention to robbery doesn’t alter the fact of robbery. In the USA, under what particular circumstances does inventive activity get you off the infringement hook?
Are you not familiar with the notion of the patent right being a negative right?
This is 1L stuff in the States.
Are you alluding to the fundamental concept of patent law that the right given by grant is a right to exclude (as opposed to a right to practise the subject matter claimed)? If so then yes, I am familiar with that concept.
And so?
Excellent baby step for you.
Now, let’s put one foot in front of the other with this:
Do you recognize the US statutory phrase “or any new and useful improvement thereof”…?
Yes, anon, improvement patents. So what?
A invents a new and useful machine, and patents it. B invents an improvement and patents that. C copies B’s improved machine. C infringes both the basic and the improvement patent.
So far, so good. What I am enquiring after is how B could argue that it does not infringe A’s basic patent.
I acknowledge the “reverse” doctrine of equivalents but had not appreciated that one can use it to avoid infringement by showing that your accused embodiment is an improvement on the embodiment illustrated in the specification of the basic patent. That strikes me as somewhat somewhat alarmist, far-fetched and divorced from present day reality. But feel free, you guys, to school me further.
Please don’t mix what I am presenting with what Night Writer is presenting.
My point is quite different.
The combination points out the very real possibility that (with your implied timing of A’s advance still under patent protection) that there is nothing wrong with B having protection AND not being to actually make anything (no objective physical structure).
I point this out not only for your benefit but also for many (typically anti’s) that seem to always forget that patents are a Negative Right.
As to your instant question of “how could B argue” IF he does ‘make,’ that he does not infringe, that would be highly fact specific, with such matters as to whether or not A even has a (current) patent or not, but generally speaking, presuming that A does have an enforceable patent, and B (and C, for that matter) practice within the scope of A, they will infringe, even if their advance is indeed a separably patentable advance.
This last point is also something that I have chastised Random about, as his views (taken to their ‘logical’ ends) would dictate that A’s patent “must be” invalid as it did not enable B’s advance, and B would still be infringing.
Random’s view is an ultra-wooden view that does not encompass the actual nature of the two steps I have presented here.
Look up the reverse doctrine of equivalents, Max. Google scholar case law with CAFC selected.
I looked it up and found this: “In Roche Palo Alto LLC v. Apotex, Inc., 531 F.3d 1372 (Fed. Cir. 2008): the Federal Circuit “has never affirmed a finding of non-infringement under the reverse doctrine of equivalents.”
That was 2008 and remains true to this day. Frankly, any patent applicant or litigant suggesting victory under the RDOE is probably committing malpractice.
link to scholar.google.com
Here Max. Read this case and it explains it well. Obviously, I am speaking prescriptively of how enablement should and (did).
Night Writer,
What are you referring to with the notion of “probably should be wider than that?”
Just that I think “any” is more restrictive than a POSITA.
If I understand you then, you would have it so enablement is met, even if a Person Having Ordinary Skill In The Art could NOT ‘figure it out,’ but (somehow) it still could be ‘figured out’….?
I really cannot tell how you intend to differentiate from PHOSITA.
Nevertheless, Holland Furniture remains a crucial decision that precludes (a) genus claims built upon on the disclosure of a single species,
/golfclap
The Federal Circuit’s failure to rely upon Holland Furniture likely stems from the fact that the case served as the foundation for Walker v. Halliburton that was later rejected by the 1952 Patent Act.
Holland Furniture is both an enablement (not all three parts/one part glues achieved the function) and an indefiniteness (functional at the point of novelty) case. Halliburton is just an indefiniteness case – which is why it mostly relies upon Gen Elec v. Wabash – and was only citing Holland Furniture for indefiniteness reasons. You wouldn’t expect to see Halliburton in an enablement opinion.
Nor was Halliburton’s substantive logic “rejected” by the 1952 act. Virtually all of the substantive requirements for a patent were carried over into the 1952 act. Halliburton was “rejected” only in its claim construction step. The law was (and still remains) that describing the novel part of a claim by recitation solely of the function achieved is indefinite. 1952 simply changed that the words “means for” no longer invoke function, but structure, so the Halliburton rule would not trigger under that patentee’s claim langauge. If today one claims the novelty of a claim by function (without availing themselves of 112f) Halliburton would still operate to render the claim indefinite.
“Nor was Halliburton’s substantive logic “rejected” by the 1952 act.”
Dead wrong.
“Point of Novelty” is gone.
Perhaps you have heard of this thing called “claim as a whole”….
>“Point of Novelty” is gone.
That might be a possible distinguishing argument in the future. These were single element claims; you never see that kind of claim in the “grown-up arts.”
Not sure what it would mean to say “‘[p]oint of novelty’ is gone.” If an examiner or an IPR petitioner or an infringer says that your claim is anticipated by document X, you are going to respond by pointing to some element of your claim that is not present in X. Whatever element you cite, that is the point of novelty. There is no possible way to run a patent system that does not—when novelty is put at issue—require that one identify the point of novelty, even if only by saying “the novelty lies in the original arrangement of these old integers.”
Incidentally, the phrase “claim as a whole” occurs in §103, not in §§ 101, 102, or 112. Just as it is statutorily improper to import the §103 obviousness analysis in the §101 subject matter eligibility inquiry, it is equally improper to import the statutory “claim as a whole” analysis from §103 into the §112(b) clarity inquiry.
When assessing clarity, it is both proper and necessary to break the claim down into its component phrases and ask whether each individual phrase is sufficiently clear. Remember, doctrine of equivalents is assessed element-by-element and not based on the claim as a whole (Warner-Jenkinson Co. v. Hilton Davis Chem., 520 U.S. 17, 29 (1997)), so it is essential—if claims are to achieve the notice function that Congress intended when it promulgated §112(b)—that §112(b) concern itself with each separate clause of a claim (including the point of novelty) and not only with the claim as a whole. Any application of the clarity tests that depends on “as a whole” analysis is proceeding contrary to the statute, which does not include the words “as a whole” in §112.
Greg is being obtuse as to how the phrase is wielded in the 101 sense.
As well as how “claim as a whole” fits 101.
No real surprise there.
The “b” hidden link is just one attorney being a bad attorney.
Nothing to write home about, and certainly nothing to hide into a patent law blog.
Greg is not only obtuse, his
L
I
E
S
are exposed in that he has previously asserted that he cannot even see my posts, and yet, he chooses to respond on point to BOTH of my points (while OC had only mentioned one of the two points).
He must have not only seen my post, he also read it AND chose to respond in a false manner.
anon, are you sure you are not really an AI generated 🥨.
don’t you know, sarah that I — just like everyone else — are only figments of your imagination in the dreamscape of your enduring nightmare?
Have you tried throwing some of your long-running concerns into an AI as prompts yes?
It’s true, if an invention is supposedly improved and rewritten as an improvement, yes it does infringe. And if it is again redone, same there too. Where do you think you got the idea from? Please anon, stop the pretzel mindset where you are always right, and everyone else is just stu….pid.
Do not be confused sarah, as what I say IS correct, not because it is I that says them – I merely choose things that ARE correct as is my typical process of having an informed opinion.
Also do not overstate that that those I disagree with are considered “stu….pid,” as I DO also agree with folk (using the ‘+1’ as well as augmenting positions I agree with).
I WILL pound those who persevere in being misinformed, but this is not a bug, but a feature.
One more quick thought about “as a whole” outside the §103 analysis. As noted above, the phrase “as a whole” occurs only in §103, and not in §§ 101, 102, or 112. Does that mean that “as a whole” is irrelevant to considerations other than obviousness?
No, it does not. In particular, the Court has explained that “[i]n determining the eligibility… under § 101,… claims must be considered as a whole.” Diamond v. Diehr, 450 U.S. 175, 188 (1981). It is notable, however, that the Court does not cite any statutory warrant for this proposition. Rather, this rule is part of the common law of patents.
This is significant because it has become commonplace to see folks argue that because Art. I, §8, cl. 8 assigns to Congress the power to enact patent laws, that therefore the Court has no power to craft common law for U.S. patents. The idea seems to be that the Constitution makes U.S. patent law to be a species of civil law, with no room for judge made law.
I think that this idea is nonsense on stilts. If, however, one credits this approach to patent law, then it follows that one should not regard the Diehr “claim as a whole” approach as law. To the patents-are-constitutionally-civil-law proponents, the Diehr rule is ultra vires, because the statute does not provide for an as-a-whole analysis of subject matter eligibility. This conclusion helps to make clear why the patents-are-civil-law proponents are expounding nonsense.
Greg’s own views ARE nonsense on stilts.
(AND — clearly — he can (and is — reading my comments: hence, his attempted backpedalling (as awful as it is).
A post about Greg’s propaganda-addicted Drum hidden link in “abo[v]e” has been caught in a filter…
… or perhaps Crouch’s own “Vast Middle Ground.
If today one claims the novelty of a claim by function (without availing themselves of 112f) Halliburton would still operate to render the claim indefinite.
This is basically correct, except that under Williamson v. Citrix Online, 792 F.3d 1339 (Fed. Cir. 2015) (en banc), it is no longer just the patentee who decides whether to give a §112(f) construction to a functional limitation. Even where a functional claim term is not phrased in “means for” form, either party can move to give the functional term a construction under §112(f). Id. at 1348.
Drum shouldn’t be hidden – he shouldn’t be linked to.
>Williamson v. Citrix Online
I wonder whether, had the Fed. Cir. applied Williamson to convert the actual claim language into a means-for or step-for limitation (despite the lack of the statutory magic words), the patentee would have won. That is, would the statutory “and equivalents thereof” have saved them here? In some ways, this might be the worst of both worlds for the patentee…the downsides of 112(f) practice without the upsides.
Side note: why doesn’t pharma drop in a means/step claim set just in case. It can’t just be extra claim fees, can it??
why doesn’t pharma drop in a means/step claim set just in case. It can’t just be extra claim fees, can it??
I could write a book in answer to this question, but unfortunately not without violating my professional duties of client confidentiality. I will say this much: there are reasons; they are not necessarily good reasons; it is not the claim fees.
Certainly you can share the reasons at a conceptual level without violating ANY legal ethics.
… and it appears that I have overestimated SJM.
Again.