by Dennis Crouch
The USPTO has published new examination guidelines regarding the enablement requirement for utility patent applications in light of the Supreme Court’s May 2023 decision in Amgen v. Sanofi, 143 S. Ct. 1243 (2023). As I explain below, the primary takeaway from the published examination guidelines is that the PTO will continue business as usual — i.e., Amgen did not significantly change the law. Still, there are, some key points to consider. Notably, the guidelines: (1) provide a reminder that enablement applies to all technology areas, not just biotech; and (2) suggests that the office may increase its assertion of the enablement doctrine against functionally defined claim limitations that are potentially directed to a large number of embodiments.
Background on Amgen v. Sanofi: In its unanimous opinion, the Supreme Court affirmed that Amgen’s broad functional claim was invalid having failed the requirements that claims must be enabled to their full scope, allowing for “a reasonable amount of experimentation.” Amgen. The claim at issue included a key broad functional element — covering all antibodies capable of binding with and disabling a particular enzyme (PCSK9). Although the Federal Circuit commented negatively on the functional aspect of the claim, the Supreme Court noted that there is no special rule for functional claims. Still, functional claims can often be suspect on enablement grounds because of their potential breadth that goes well beyond tech disclosed. The result then is a simple rule: broader claims require more detailed disclosure.
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. . . . The more one claims, the more one must enable.
Id. To be clear the specification is not required to “describe with particularity how to make and use every single embodiment within a claimed class.” Id. In fact, I would posit that in most situations it is effectively impossible to describe all potential embodiments covered by a modern comprising-style patent claim. Instead of fully describing every potentiality, the court concluded that the specification must provide enough disclosure to “reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset” allowing for a reasonable amount of experimentation. Id. The threshold for enablement can often be difficult to ascertain, but here the Supreme Court made clear that Amgen’s specification was more of a research assignment than an enabling disclosure. The Court also noted that whether experimentation is reasonable depends on the context, citing Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916).
Two potential Points of Confusion: The Supreme Court’s analysis in Amgen introduced two potential points of confusion regarding enablement doctrine. First, while citing a litany of its own old precedent on enablement related to technologies like telegraphs and incandescent light, the Court did not explicitly reference leading contemporary Federal Circuit decisions that articulate enablement standards. Most notably, Amgen does not mention In re Wands, 858 F.2d 731 (Fed. Cir. 1988) and its seminal “Wands factors” that are regularly relied upon by patent examiners and litigants to assess if PHOSITA would need to conduct an unreasonable amount of experimentation in order to make and use the invention. These Wands factors include:
- (A) the breadth of the claims;
- (B) the nature of the invention;
- (C) the state of the prior art;
- (D) the level of one of ordinary skill;
- (E) the level of predictability in the art;
- (F) the amount of direction provided by the inventor;
- (G) the existence of working examples; and
- (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Wands (noting that this is not an exhaustive list of potential factors). Although relied upon daily in the patent system, the Supreme Court did not reference the Wands factors in its analysis. This omission created a question of whether Wands and its factors are still applicable.
The second issue is related to the first, and it has to do with a subtle shift in the language that the court used in forming the test. In Amgen, the Supreme Court offered repeated reference to “reasonable experimentation” rather than the typical “undue experimentation” standard. This difference introduced potential confusion on whether the Court announced a distinct, new test.
In post Amgen cases, the Federal Circuit has resolved these two subtle points of confusion, holding (1) that there is no difference between the traditional statement of “without undue experimentation” and the Supreme Court’s similar wording of a “reasonable” amount of experimentation; and (2) that the Wands Factors continue to serve as the key approach to determining whether the amount of experimentation needed to make & use the invention is too much. The case that explains this best is probably Baxalta Incorporated v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023).
Its new guidelines, published January 10, 2024, the PTO reviews Amgen and post-Amgen case law and concludes that examiners will continue applying the long-standing “undue experimentation” standard and In re Wands factors when evaluating enablement. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 83 Fed. Reg. 1563 (Jan. 10, 2024).
From my initial review, these guidelines do not appear remarkable, but simply serves the purpose of keeping everyone on the same page. It remains to be seen whether the examiner corps will further increase its focus on functional genus claims – especially those directed to a large number of embodiments and whether examiners outside the traditional ‘unpredictable arts’ will alter their enablement examination practice.
To be clear, these are examination guidelines – guidance for patent examiners that supplement the Manual of Patent Examination Practice (MPEP). They are not “rules” and do not have the force of law.
The Wands factors are not particularly illuminating. Some are just sort of dumb (e.g., the first two). Others, like working examples, are probably a good consideration, but other case law undermines them (e.g., prophetic examples are treated kindly). And how exactly do the factors even relate to each other? How do they guide one toward a decision on unreasonable experimentation?
It’s bad enough that the factors are indeterminate, but it’s also cumbersome to make a decider walk through an 8-factor test. Clearly the ultimate test has to at least connect the disclosure to real-world improvements in making and using the claimed invention, compared to the prior art.
So Kyle, refresh my memory – you are neither an examiner nor a registered practitioner, eh?
What is you role again?
I’m a registered practitioner and a patent litigator. I have not prosecuted patents. Thanks.
Thanks – that’s what I thought.
more gibberish from admitted paid to post “anon” aka Snowflake.
we’re shutting down this thread and closing comments.
More coin from you in your false characterizations that we have been over MANY times now there, Shifty.
We both know that I have enterprised obtaining coin BASED ON YOUR CHOICES of how you post.
You have full control over that and it is YOU that generates coin for me.
Your notion of “shutting down” is hilarious, given your abject 0bsess10n over me.
try to focus Snowflake. we’re shutting the comments down.
Please Pardon Potential re(P)eat…
Your comment is awaiting moderation.
January 29, 2024 at 10:00 am
You keep on saying that – and keep on showing that you have no control with your 0bsess10n over me.
Sorry. We’re closing comments.
Please Pardon Potential re(P)eat…
Your comment is awaiting moderation.
January 31, 2024 at 7:23 am
Thank$ – (you already asserted that)
the admittably paid to to post anon has never pretended to be a “litigator.”. only pretended to be a mere “prosecutor.”. what irving kayton called a patent solicitor,
you might be thinking of Hal Wegner. Remember that tiny Miata he used to drive?
i fo. but that begs the wuestion why does anon pretend to be s mere “prosecutor?”. he could pretend to be so much more.
Ah Shifty, “mice” to see your choices (and obsess10n) bringing me coin in the new year.
Please Pardon Potential re(P)eat…
Your comment is awaiting moderation.
January 15, 2024 at 11:23 am
…
your talking to yourself reminds me of:
H1ck0ry
D1ck0ry
&
D0ck
i was not talking to you, Snowflake. Why your obsession?
To or about me IS your obsess10n…
Thanks for the choice in trying to coopt my writings – nice double coin on that choice of yours.
who in your troubled mind do you think you’re talking to, Snowflake? who are these “mice?”
Please Pardon Potential re(P)eat….
Your comment is awaiting moderation.
January 18, 2024 at 8:21 am
Shifty,
Please tell me you know how to research H1ck0ry D1ck0ry D0ck…
he could be pretend so much more
.. or not pretend at all (as is the case)
But you, my pal Shifty, cannot pretend that you are not 0bsessed with me.
You’ve climbed back over 98.5 % of your posts being to or about me.
No one on this blog even comes close to your singular 0bsess10n.
i know. he could pretend to be one of those dupreme court judges and get paid way more.
still don’t why Snowflake is so obsessed with you. what do you look like?
he could pretend to be the most supreme being in the universe and probably get a handsome pay bump.
Another Trifold payout from the choices of my pal Shifty and his choices 0bsess1ng over me.
Thank $ $ $.
i think he just did.
Did you have something that you wanted to share with the class?
yeah but why dose Polly’s talks always be about how she invented re-exams?
Always?
I think that be a bit myopic of you.
She is far more interested in her dissents to stem the tide of a “Desired Narrative” of the rest of the bench.
(excited that an actual conversation might break out!)
why does he pretend so low?
his mother said he could hsve pretended so much more
someday he might crawl out the basement
4x choices that earn me coin.
Thank$
Thank$
Thank$
Thank$
i think he just did.
reminder: toor about.
Your 0bsess10n persists.
Snowflake gets schooled from time to time and gets really mad and stamps his foot but i guess there is no but
I chuckled at the thought that you think that your nonsensical obsess10n schools anyone.
And please, the projection of anger is simply unfounded, as I practically always get the best of you (no foot stamping required).
so you think the admittedly paid to post”Anon” determines when we close comments?
i did not say that. i said he gets schooled from time to time. but thats true too.
True that he thinks that.
The value of the coin that YOUR CHOICES earn me has been provided many times now, my pal Shifty.
And thank$$$$ again for your choice$.
it was actually a bit comical
Comical?
Well one could view it that way, but that certainly would not be in your favor.
Most though would see your overwhelming 0bsess10n with me (at well over a 98% SINGULAR focus) as being more than a bit unsettling.
Shall we review the term “cyber stalking” again?
Just what do you think I was commenting on, Snowflake?
Serious question.
That’s not a serious question.
You have not posed a serious question as far back as I can go.
he was not talking to you, Snowflake. is this where your “98 percent” comes from?
cyberstalking i will not turn you in to management. not your fault you answer what was not asked. the paid to post thing we understand.
Two more instances of coin to me from your choices, my pal with the shifting pseudonyms.
As many times pointed out now, “to OR about me.”
That you do this through the subterfuge of you talking to yourself f00ls no one – you have several times now ‘oopsied’ with messing up your pseudonyms and different email addresses.
These attempts of yours are just you trying to dig your way out of a rather large hole that you have dug yourself into.
more gibberish. we’re closing comments.
Your accusation has no merit.
Your “closing down” is thus seen as what it is: your retreat when your f001ishness is exposed.
Again.
whatever became of him?
Good question. Do you know?
(is there a chance that an actual discussion with substance may yet surface on this thread?)
you never heard of irving kayton or hal wegner. you are such a remarkably transparent posuer, Snowflake.
Baseless accusations my pal Shifty.
I likely know Hal better than you.
[sigh]. his mom thought someday he’d pretend to have known Irving Kayton. only hal.
Someone needs to buy anon a change machine. Maybe he will make enough to see Richard’s old flame Dr. RUTH.
The “[sigh]” is a bit odd, but nonetheless, thank$$ for your choice of posting that provides me yet more coin.
We almost made it to a real discussion.
the tragedy is. Snowflake could have pretended to be so much more.
but his older sister’s palmist’s manicurist’s neighbor’s mail person’s neighbor’s restrained pararakeet’s gerbil must be proud,
The real tragedy is that you spend any amount of time so helplessly trying to be witty in your 0bsess10n over me when you simply cannot compete.
Your volume simply is not good enough, Shifty.
you mean when he got so confused he called himself a liar? or the time he cut and pasted from Wikipedia and Wikipedia was wrong? or the time he designated his own expert and his expert concluded he was an incredibly sloppy reader, writer , and thinker? or are you referring to some of those other times?
I see that you have finally glommed onto your error in your Wikipedia disaster…
But you still haven’t caught on to your other disasters.
But YOUR choices in not doing so are what earn me coin, so (again), thank$$$
Of course, you are comparing nothingburger to prior law, not to what the Court might have ruled if it had accepted Amgen’s arguments. Full scope enablement may not be a change, but it is far from a nothingburger if one had to only enable one or some limited number of embodiments of a claim….
Very true.
On the facts of THIS case…
How often will we see those facts again?
Other than that Mrs. Lincoln, how was the play?
(The USPTO interpretation DOES make it a nothingburger given how closely it hewed to the facts of the case)
We have seen basically the same case several times even since Amgen. Not an uncommon fact pattern in the bio space.
And from the litigator’s perspective – how do you view the USPTO’s Federal Notice write-up on its interpretation of this case?
You know, focusing on how they stuck tightly to the facts, drawing to the (immature art of) unpredictable arts.
Also pops up a fair bit in the tech space, especially in situations where continuations are drafted to cover products already on the market. I probably deal with between one and three cases a year that have the full scope enablement issue.
I have never seen this in the tech space for well over 17 years.
… to clarify: in the tech space while in prosecution (and somewhat more limited litigation).
so sad. he could have pretended to be so much more.
well, let’s make that 5x
so, I will another Thank$
As I said in connection with another article, in 9/10 cases where there is an enablement/written description rejections, the rejection is based on the Examiner’s lack of understanding, and not whether the person of ordinary skill would not have understood the claim (likewise with a significant number of indefiniteness rejections). Throw the Wands factors back at the Examiner and the rejection is usually withdrawn, especially when you point out that the Examiner has failed to state the level of ordinary skill.