by Dennis Crouch
HZNP Finance Limited v. Actavis Laboratories UT, Inc. (Fed. Cir. 2020) [En Banc Order][Original Panel Decision]
In an 8-4 Federal Circuit has denied HZNP’s petition for en banc rehearing over a vigorous dissent from Judge Lourie (joined by Judges Newman, O’Malley, and Stoll).
The focus of the petition is the “reasonable certainty” indefiniteness standard in relation to the un-expressed elements of an invention claimed using the transitional phrase “consisting essentially of.” In its original October 2019 holding, the Federal Circuit explained that the “consisting essential of” transition indicates that the claim requires the listed elements and is also “open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.” In that framework, the “basic and novel properties of the invention” become a claim limitation that itself must be definite.
HZNP’s claim at issue here is directed to a pain-treatment ointment “consisting essentially of” 2% diclofenac sodium; 40% DMSO; etc. (Sold as PENNSAID). The specification indicated that “better drying time” was one of the improvements provided by the invention. The specification provided two methods of evaluating better drying time. However, those methods were ruled inconsistent and without a standard for PHOSITA to evaluate drying time. Since the novel feature was indefinite, the court found that the claim itself was indefinite.
This outcome is clearly problematic for current patent application drafting practice because only a minority of patent applications expressly identify and explain the novel features of the invention. One reason why those are not explained apriori is that the inventor’s understanding of novelty shifts as the patent application moves through the patenting process (or even later during litigation) and more prior art is unearthed. Although not entirely clear, it looks to me that the proposed method of claim interpretation uses a more subjective novelty — what did the patent applicant think was the novel feature.
In its en banc petition, HZNP asked the Federal Circuit to hold that the “basic and novel properties” were not claim elements and thus not subject to the “reasonable certainty” requirements of Nautilus and 112(b). The patentee provided three separate arguments:
- The plain language of 35 U.S.C. § 112, ¶ 2 restricts application of the definiteness standard to claim limitations;
- The “basic and novel properties” of the invention are not claim limitations since an infringer need not practice those properties in order to infringe; and
- Our tradition has never applied the definiteness standard to the “basic and novel properties” of an invention.
Judge Newman dissented in the original panel decision and joined Judge Lourie’s dissent from en banc rehearing. The basic thrust of the dissents is as following:
Better drying time is not in the claim, and it is the claims that the statute requires be definite.
Dissent. The dissent also notes that the patentee likely created the problems here by providing two methods of measuring — “one wonders whether, if this patent did not recite the methods by which better drying time was measured, any indefiniteness of the “consisting essentially of” language would have arisen at all.”
The question I would ask is whether we should require disclosure of the basic and novel properties of the invention as part of every patent specification — perhaps as part of the written description requirement. The dissent appears to assume that these are a requirement of the utility doctrine — but notes that utility is such an easy test that it is not even challenged unless “not credible.”
Worth posting on top in response to Greg at 4.2.2.2.1.1, since my pal Shifty has seen to insert his game-playing into the thread:
Let’s note Greg’s legal fallacy of a bit of a strawman with his notion that a “problem” is knowing a field so well so as to make some optional claim format easier to do well.
What Greg really means is that for some art fields that want to advance along a very small and easily identified incremental step, the optional claim format under discussion is easier to do well.
Well, no duh.
But that has nothing to do with some desire of Greg’s to force this option on all others.
Quite in fact, there is harm to innovation in forcing the optional term to be a mandatory term. The harm is that it forces innovators to focus ONLY on the incremental. For established large scale entities, not only is such perfectly fine, such is actually very much preferred. The chance of something being granted that turns out to be a disruptive game changer is lessoned if innovators are forced to put their claims in a purposefully “incremental” mode.
Worth repeating (but not quite at the top).
In reply to snark from my pal of the ever-shifting historical pseudonyms:
Most talk here is of the point-counter-point variety, and to my point of:
“It’s simply asinine and professionally irresponsible to suggest otherwise.”
counter points seem to come only from the likes of game-playing Shifty, and ever-barking-up-the-wrong-tree NSII.
The inventor cannot actually “know” what is novel about his invention. If he did, why would we need a patent examiner in the first place?
I think that you are using “know” in two different senses.
First know: believes as one’s own.
Second know: verify the veracity of.
Somewhat Rumsfeldian.
This is a bad opinion. First, I note that the original opinion is by Prost (liberal arts got the appointment ’cause she be a good helper on the judicial committee) and Reyna (got his appointment by SV for not liking patents and being completely ignorant of patent law and science. Thanks Obama.)
So, two people that know nothing about science or innovation fabricate some shxt and we are going to have to live with it.
This is a bit crazy really as the novel feature may got to non-obviousness and functionality to the elements, but definiteness?
So now the judges get to dig into the specification and if they feel that improvements of the invention are not definiteness for their untrained minds that know nothing about science then the tyrants can invalidate the claims for being indefinite. The proper way to do this would be use the improvements only for non-obviousness. The argument for this is well known.
Wow. New levels of madness at the CAFC. The only hope is if Trump wins really big and we can get him to wipe out the CAFC. This opinion should be cited as one of the reasons and people like Taranto.
Move to get the CAFC wiped. It could be done in a day. Pass a law to wipe it out and the jurisprudence since 2011 and then pass a new law to reform a CAFC and let Trump appoint judges with science and patent law backgrounds.
We need to build a case to wipe the CAFC.
I think with a concerted effort that it is a realistic goal to get the CAFC wiped. If Trump wins big and we put together a good case with example opinions and Trump realizes that most of these people are Obama appointments with no science education, then it would be possible.
A contrary force:
“and Trump realizes that most of these people … with no science education” with results positive for Big Business…
Leads in exactly the opposite direction.
Sorry Night Writer, but Trump is just not going to be the panacea you want. Further, the action of disbanding (or better yet, the action of removing the Supreme Court from actions not of their original jurisdiction and reforming a literate Article III CAFC would NOT be with the Executive Branch to begin with, but would be with the Legislative Branch.
Your “Obama” focus is more a matter of timing than it is of which branch gets to disband (or reassemble) parts of the Judicial Branch. The Checks and Balances power necessary here is not as you might desire.
Meh, I was taught that “consisting essentially of” was a special transition term useful when claiming a chemical compound, e.g., pharma. A way of capturing the invention with a little room to vary the composition amount but still achieve the inventive nature of the compound. But what do I know, I was actually taught patent law in a class room, you know policy, the reasons why such a transition is needed, law, how to write a claim, etc. This CAFC is the LAW. Thanks Obama!
“but notes that utility is such an easy test that it is not even challenged unless “not credible.””
I certainly hope that you teach WHY this is so in your patent law classes.
“The question I would ask is whether we should require disclosure of the basic and novel properties of the invention”
As sympathetic as I am to the idea, I find myself struggling to justify a “recognition” component to possession.
Someone who just vomits ABCD…Z into claims, where FRX together happens to be novel/non-obv should probably be considered an inventor, even if they have no idea what they invented.
Someone who just vomits ABCD…Z into claims, where FRX together happens to be novel/non-obv should probably be considered an inventor, even if they have no idea what they invented.
“Should”? Why so? What policy good is advanced by that rule?
In theory, in the absence of the ability to obtain a patent, an unwitting inventor might never disclose the invention nor develop it into a commercial good or service. Assuming the disclosure has value, one might rationally encourage such disclosures.
To incentivize disclosure, it’s good for inventors to be able to get the whole scope of what they deserve. We don’t want their rewards to be limited to what they initially recognize, but what they actually contributed. It’s a good thing that with decent drafting, the inventor of FRX (Post #6) will likely be able to broaden their claim beyond what they originally claimed, because this will allow their reward to better match their contribution.
I also wonder about 112(a) issues and Jepson claim amendments. Your example of amending a genus to a species is the exception not the rule. I sincerely do not know how 112(a) applies to these claims. If I originally claim ‘AB, where the improvement is C’, while disclosing ABCD but not identifying anything beyond C as novel, can I later claim ‘AB, where the improvement is CD‘?
Perhaps this would be an appropriate compromise?
First, exclude ‘recognition of the improvement’ from the written description requirement.
Second, allow submission of claims in non-jepson format, and require the office to examine those claims as they are examined today.
Third, prohibit issuance of non-jepson claims.
Basically, create a system where applicants need not know their contribution initially, but end up getting only a claim which clearly identifies their contribution.
That seems vastly more fair than just requiring jepson format.
Is your idea for the life of the patent, or only ‘flexible’ prior to grant?
Because you seem to start done a path of “what is actually shared” but you curtail it based on factors still outside the control of the applicant (the ‘what is actually shared’ is ephemeral).
The jump from your second to your third is the “devil of the details.”
Without that step FULLY explained, why exactly would your idea be a “compromise” worth considering?
Greg, perhaps it would help the hard-pressed judges, to adopt the following:
1. The claim must define the invention as a new combination of technical features.
2. Patentability is to be assessed paying due regard to the technical effects delivered by the new feature combination. In other words, toggle between features and effects, to settle patentability elative to the state of the art.
3. The definition provided by the claim must be “definite” to the extent that competitors know whether their acts, their feature combinations, are inside or outside the ambit of the claim.
Because, if they do all that, it is easy for the courts to decide on the validity of the claim, irrespective whether or not it is in Jepson form.
Personally, based on my EPO experience, I am not in favour of forcing all claims into a Jepson form. Perhaps in chem/bio, Jepson form is tolerable. Not always in engineering cases though.
I expect that most all patent attorneys would say that, “while Jepson format might work for [X art field], it will not work for my clients’ art field.” No one wants to use Jepson, which is why use of Jepson will need to be required (either by statute or regulation) in order for its use to become commonplace.
I confess, in other words, that I am skeptical of your assertion here, Max. Perhaps, however, you could help me to see the sense of your point by providing an example of an art art picture and an invention that would be impossible to claim in Jepson format?
In chem/bio, Greg, different specifications use a common terminology but in mech eng each writer uses their own terminology. When that happens, there can be during prosecution at the EPO a genuine dispute whether a feature recited in the claim is or is not disclosed in D1, the prior art starting point for a c-i-t form of claim. Thus, the Examiner insists that the “widget” element which I have in my claim is found in D1 as its “dooberry” element. They are the same, declares the Examiner. No, they are not 1:1 the same, I reply, not to be equated, not to be adjudged to be synonyms. To do that, I assert, is to short change the inventor, mis-characterize their contribution to the art and so is unnecessarily unfair to the inventor, denying that inventor a scope of protection commensurate with their contribution to the art..
That’s one situation, the one that springs immediately to mind. There are surely many more.
I have long argued that Jepson and c-i-t are NOT the same. Perhaps our discussion here will make or break that assertion.
… in other words, you realized only after your post that you had contradicted yourself (as has been pointed out to in discussions past)…
How is the possibility of a misunderstanding of vocabulary relevant to the Jepson or not Jepson discussion? One can have misunderstandings of vocabulary regardless of claim format. I do not see that the one is especially relevant to the other.
As for c-i-t vs. Jepson, I am also not clear why this would be relevant to the present discussion. If c-i-t is different from Jepson, then it is different. Fine. Coming back to Jepson, what is an example of an invention (and an art picture behind the invention) that cannot be properly claimed in Jepson?
I will happily concede that it will be harder to claim in Jepson. Jepson claims are difficult to do right, which is why most professionals prefer to steer clear of them. While they are harder for the patentee, however, they are easier for the courts and for the regulated public. The patent system should always be structured to maximize benefits for the public.
Progress. Writing a Jepson right is, you say, “difficult to do right”. Writing an accurate c-i-t claim, is either straightforward or not possible, depending on the facts. Amendments during prosecution in the USA, if made in Patent Offices outside the USA, can render invalid those patent family members outside the USA.
But if you want drafting and claims that facilitate assessment by competitors, courts and the public, the most important step is to require drafters to do it in accordance with the PCT Rule 5 and thus the EPO’s “problem/solution approach” to non-obviousness.
link to wipo.int
Completely disagree.
It cannot be the most important to disregard a Sovereign’s choices of how that Sovereign has chosen to implement what has always been a Soveregin-centric area of law.
It is not — and never has been — an issue of “cannot” or “impossible to.”
These are legal fallacy positions Greg.
“The patent system should always be structured to maximize benefits for the public.”
YOUR version of ‘benefit the public’ is simply not the one that is either in place, or accepted by most all (outside of the picture-claim Big Pharma types).
The public IS maximized by the Quid Pro Quo. That Quid Pro Quo has never been about a forced Jepson claim format manner of the exchange between the government and the innovator that turn’s the innovator’s inchoate right into a full legal personal property right.
Methinks that your “the public” notion is more than a bit overplayed.
Re: “The question I would ask is whether we should require disclosure of the basic and novel properties of the invention as part of every patent specification.”
The “make and use” requirement of 112 should require some of that. But many U.S. applications are filed with no or very limited prior art searches. What are actually novel properties and what is validly claimable may well turn out from examination or reexamination prior art to be far less or different than originally thought when the specification was written.
Due to the influence of court-induced ‘patent profanity,’ the comment of “But many U.S. applications are filed with no or very limited prior art searches” — coupled with the fact that there is no legal requirement for ANY prior art search, must also put the comment of “ what is validly claimable may well turn out from examination or reexamination prior art to be far … different than originally thought when the specification was written.” into a context in which the applicant is not presumptively concluded to be “hiding the invention.”
It’s simply asinine and professionally irresponsible to suggest otherwise.
Interesting! Why is it nobody talks to you, Snowflake?
Most talk here is of the point-counter-point variety, and to my point of:
“It’s simply asinine and professionally irresponsible to suggest otherwise.”
counter points seem to come only from the likes of game-playing Shifty, and ever-barking-up-the-wrong-tree NSII.
Thank you Shifty, for the attempted snark that proves my immediate point at hand.
I know, don’t get you riled. You might cut and paste from the Internet. No lie, I’ve seen him do it!!!
Way to conflate your scripts, Shifty.
And yet again, you prove my point. In case you missed the last sentence of the post that you responded to, thank you again.
So it’s true. You are no longer able to cut and paste from the Internet.
Who? Who said he’s no longer able to cut and paste from the Internet?
Shifty,
What is it that you think that you mean by:
“So it’s true. You are no longer able to cut and paste from the Internet.”
Have you run into some difficulties? Is that why you stopped providing those funny gifs?
Oh, Snowflake. All this “last sentence of the post that you responded to” stuff is all in your mind. Can you see that?
My thanking you is all in my mind?
Pretty sure that’s not the case as I expressed my gratitude.
It’s right there in black and white.
Or are you having difficulties again with that whole concept of things being in black and white again?
Yeah, right, Snowflake. Now compare the comment and your response. What color is the sky in your world?
And still no cut and paste from the Internet. So, it’s true.
Maybe my pal, it’s this dissociative effect of shifting from one historical pseudonym to another — yet also the tendency to speak of yourself in plural — that is causing you your apparent difficulties…?
So it’s some kind of “shifting” that make you unable to cut and paste from the Internet? Have you sought professional help?
I suppose that the letters
y
o
u
r
don’t mean anything to
y
o
u
Yes. Do you have a point?
You just made it.
For me.
No. Do you have a point?
Yes.
You just made it.
For me.
We’re sure you think so. You will need to enlighten the less addled as to what you think your point is. Fill the room with your intelligence.
You telling me what I need is pretty funny.
Not as funny as those gifs you used to provide.
Maybe go back to those?
What are actually novel properties and what is validly claimable may well turn out from examination or reexamination prior art to be far less or different than originally thought when the specification was written.
Very true. Surely, however, this is not all that much of a problem. Either the application really does disclose novel and nonobvious subject matter or it does not. If it does, then as this or that aspect of the putative invention is discovered not actually to be new, the spec (and claims, in a Jepson-obligatory world) can be amended to revise the “this is the new bit” disclosure as necessary. If the application does not actually disclose any novel and nonobvious subject matter relative to the prior art on the day before filing, then presumably the app will be abandoned, and no one will much care about the accuracy of its “this is the novel bit” disclosure.
Greg, I don’t accept your cavalier dismissal of the problem of dealing during PTO prosecution with prior art much closer to the subject matter of the application as filed than the prior art known at the time of writing the specification. At least at the EPO, inventors who put the best known art in the hands of their drafters before they start drafting are much more likely to get to issue with claims of a scope commensurate with the inventor’s objectively defined contribution to the art.
The irony of “don’t accept your cavalier dismissal” is actually delightful.
Here, Greg is using his (see my ‘whipped out’) credentials of Big Pharma bias as HIS spectacles to see ALL of patent law, and is being challenged by the guy who uses his own spectacles of “EPO Uber Alles” to view US Sovereign patent law.
[I]nventors who put the best known art in the hands of their drafters before they start drafting are much more likely to get to issue with claims of a scope commensurate with the inventor’s objectively defined contribution to the art.
Sure, but that is a problem that only affects the patentee (not the public), and one that the patentee has largely the power to control. There is no need for the legal system to create guardrails to save the patentee from his/her own carelessness. If the applicant does not wish to do a good search before filing, than s/he takes his/her chances that s/he will end up with claims of less ample scope by the end of prosecution than s/he might otherwise have obtained. Why should the rest of us lose any sleep over this?
MaxDrei,
You raise a valid point — which carries with it the valid counterpoint that I presented at post 4.1.
That is, it is certainly ‘Best Practice’ to have the best and most thorough prior art search possibly done as an input into the drafting of a specification.
But even having ANY prior art search at all is not — and never has been — a legal requirement in the US Sovereign.
And let’s not forget that patents are legal documents, as opposed to being technical documents. As such, the rules of law outweigh considerations of the rules of “technical exactitude.”
While certainly, it MAY ‘be nice’ to fully satisfy both, in truth, and in what the documents are in fact, an attorney has a duty only to the one and not the other. In this sense, I do not mean that an attorney gets to not treat facts as facts, but instead, the focus of duty of preparing a legal document is simply a different duty than one if preparing a technical document.
What Greg advocates here is certainly NOT in the legal best interests of most ANY art unit outside of his ‘bespectacled’ Big Pharma bias.
This is ALSO why Greg ‘saw no problems’ with the Trojan Horse (or poison pill — take your pick of metaphors) of the insertions into the “Let’s fix the Supreme Court mess of eligibility” discussion of the traps of changes to 35 USC 100 and 35 USC 112 by those who simply really did not want a 101 fix at all.
Note how eager he has been to shout out “compromise” (and wheel that big beautiful horse within the city gates; or “do you need some grape Kool-aid to wash down that pill, never mind that almond after-taste”).
Why do you spend so much effort to say so little? There is no conflict between “the the rules of laws and considerations of the rules of ‘technical exactitude.’ ” If “technical exactitude” was a legal requirement for a valid patent, then that would be the rule of law. To my knowledge, no one is claiming that “technical exactitude” is currently a legal requirement. One might as well compare “technical exactitude” to FAA regulations. To the extent that you are arguing that the law is as it should be, pointing out how proposed changes to the law differ from existing law completely misses the point of proposing changes.
Why do YOU spend so much time missing the point, NS II?
Clearly, the point presented is that there is a very real difference between legal and technical, and what Greg merely wants (and sees as ‘no problem’) is driven from his Big Pharma “we have picture claims” technical view.
It seems that EVERY time you choose to comment, you bark up the wrong tree.
Ahh, now i understand why nobody tries to talk to you, Snowflake.
+1
… the company you keep (two who perpetually are taken to the woodshed, finding solace in each other)…
Only now?
Yay!
Another ‘frequent woodshed visitor’…
Who takes who to the woodshed? Ladies and gentlemen, for your entertainment, I present the poster child for the Dunning–Kruger effect. . . Snowflake!!!
Shifty,
Your self-flagellation is almost matched by your copying of the (completely ineffective) Malcolm Mooney Accuse Others meme.
Tell me again what is your line of work. It leads to some ‘impressive’ capabilities that you demonstrate so consistently.
Re: ..”the spec .. can be amended to revise the “this is the new bit” disclosure as necessary.”
? Without getting a valid “new matter” rejection?
Greg is clearly ONLY seeing the world through his Big Pharma bias.
Imagine a world in which it was a positive requirement of the application process that the application contain some statement to the effect “the basic and novel property of the invention disclosed herein is that the addition of a ketone to the imide moiety improves water solubility by 80% without detracting from the oil solubility of the drug.” Now imagine—in that world—the examiner turns up two or three references in which a ketone is added to the molecules imide moiety and water solubility is not improved. In other words, not just any ketone will do, but rather it has to be diacetyl.
Well, in that case, there are two possibilities. Hopefully for the applicant, diacetyl has been called out by name elsewhere in the application. In that case, it is not new matter to revise this required statement to read “the basic and novel property of the invention disclosed herein is that the addition of a
ketonediacetyl to the imide moiety improves water solubility by 80% without detracting from the oil solubility of the drug.”Alternatively, the applicant has not disclosed diacetyl specifically. In that case, it is not possible to revise the “basic and novel properties” statement as it must be revised without (as you note) introducing new matter. In that case, the application simply fails. Too bad, so sad, I guess that the applicant should have done the search before filing.
This is a problem for the applicant (in this hypothetical, not presently existent world), but not a problem for the rest of us. The patent system could go on just fine with such a rule in place.
Greg,
You appear to fail to consider a claim to the actual compound.
What about a chemical case where the claim is to a compound A-X-B. X is a ring structure known in the art, but with different substituents. A-X is in the art. X-B is in the art. Assume similar levels of disclosure exist for both compounds, and A-X-B could be synthesized by a PHOSITA.
However, the combination, A-X-B, is novel.
A-X-B has surprising properties, and therefore is patentable.
But, the reason it is better than A-X and the reason that it is better than X-B differ.
How would you suggest claiming this molecule in Jepson format?
One of the problems with Jepson format is that it becomes easier to do it well the more you know about the invention and the art background. Given your rather sketchy hypo, I am flying a little bit blind here. If you will forgive the limitations imposed by that lack of detail, my first pass thought would be something to the effect of “a compound having ring structure X, and decorated with substituent A at ring position K, wherein the improvement comprises decorating the ring X with substituent B at position M,” or some such.
Is there a reason why this should not be a tenable approach? I will not necessarily be surprised to discover that there is, but I confess that I am not seeing the problem right now.
Let’s note Greg’s legal fallacy of a bit of a strawman with his notion that a “problem” is knowing a field so well so as to make some optional claim format easier to do well.
What Greg really means is that for some art fields that want to advance along a very small and easily identified incremental step, the optional claim format under discussion is easier to do well.
Well, no duh.
But that has nothing to do with some desire of Greg’s to force this option on all others.
Quite in fact, there is harm to innovation in forcing the optional term to be a mandatory term. The harm is that it forces innovators to focus ONLY on the incremental. For established large scale entities, not only is such perfectly fine, such is actually very much preferred. The chance of something being granted that turns out to be a disruptive game changer is lessoned if innovators are forced to put their claims in a purposefully “incremental” mode.
Incidentally, one gets three independent claims for a basic filing fee, so why limit oneself to the single claim above. How about the following:
1. A compound having ring structure X, and decorated with substituent A at ring position K, wherein the improvement comprises decorating the ring X with substituent B at position M.
2. A compound having ring structure X, and decorated with substituent B at ring position M, wherein the improvement comprises decorating the ring X with substituent A at position K.
Greg, Congress could also require that the applicant amends the background to cite the closest prior art references relied upon in the prosecution and, for each reference, a list of the limitations of the allowed claims that are shown. For example, reference A shows A-X and reference B shows X-B. That could be sufficient to help the public understand the patent document.
“prior art references relied upon in the prosecution and, for each reference, a list of the limitations of the allowed claims that are shown.”
Under what pretense?
“sufficient to help the public understand the patent document.”
That’s not the standard. The standard is in view of PHOSITA, and thus, that legal person already fully understands ALL of what you would task the innovator to do.
Do you even get the (existing) danger of patent profanity and now want the innovator to both characterize ALL prior art AND engage in the (also otherwise innovation hurtful – see post made easy to access number 11 at top) attempted incremental differentiation….?
This is yet another huge wooden horse outside the gates of Troy.
No thank you.