Intellectual Property legislation and oversight in the Senate goes through the Intellectual Property Subcommittee of the Judiciary Committee. On June 22, the Subcommittee heard testimony on the topic of ongoing problems with “low quality patents.”
Written testimony:
- Testimony of Bridget Asay (Litigator, Lead counsel for Vermont’s consumer-protection case against patent trolling)
- Testimony of Julio Garceran (Chief IP Counsel at CREE)
- Testimony of Troy Lester (VP for Patents at Acushnet-Titleist)
- Testimony of Prof. Jorge Contreras (U.Utah)
Highlighted issues:
- It is tough to figure out the status of a patent and identity of the patent owners.
- Discussion of the Theranos-Holmes problem (patents issued and asserted even after criminal fraud indictment) — see Contreras Testimony. But generally, the problem is not seen as fraud but low-quality patents.
- Contreras — there should be more focus on reduction to practice at the examination stage.
https://www.judiciary.senate.gov/meetings/protecting-real-innovations-by-improving-patent-quality
One of the academic proposals for patent quality that this Senate Committee is apparently actually considering is “gold plated patents” issued with immunity to patent suit defenses. This is an academic proposal with many defects, which I recall being first proposed several years ago by Prof. Lemley.
Normal PTO patent examiners do not have the search tools, legal training or experience for many patent litigation validity issues, including on-sale and prior use bars, declaration evaluations, document authentications, several 112 issues, etc. Nor is a purely ex parte proceeding by non-attorneys with no or very limited discovery appropriate for deciding in advance these and other patent litigation issues. If its search and examination fees were set high enough even for mere patent and publication searches at litigation levels it would rarely be used. Especially since predicting in advance what patents will be widely infringed by others years later, rather than obsolete or not infringed, is difficult.
Not even to ask if such proposed sweeping administrative proceedings decisions usurping normally Article III judicial decisions, not even conducted by APJs, would be compatible with the recent Supreme Court decision in US v. Arthrex?
Did legislative details (of which I have not seen) include aspects that retroactively affect court (Article III) or executive branch adjudicatory functions?
BTW, “the Theranos-Holmes problem” was really the huge amount of money lost by the investors in this venture. What evidence is being offered for the implication that their numerous patent applications and patents lead to those bad investments [rather than all the PR and puffery]? Also, there seems to be underlying here the baseless lay myth that the PTO [not just the FDA] has some kind of legal responsibility or capability for examining medical devices for medical efficacy.
I do not think that it is a question of “efficacy” as much as it is a question of did the asserted patent actually have had possession of that which is being asserted at the time of filing (and thus the patent is being used to cover whatever it is that MAY have a desired efficacy — read that as a real world product on the market.
It is important that we all keep in mind what a patent is and what a patent is not: it is a negative right; it is not a positive right to actually MAKE any product that itself may have efficacy.
Mark Lemley the man who dismantled the US patent system with Silicon Valley money.
It is a little chilling to recognize just how long the “patents are bad” drumbeat of propaganda has been allowed to foster itself (generally AND through academia).
If you look at what Lemley has done to academia, then I think it is more so. He has helped a whole bunch of practicing attorneys become professors at universities writing papers with them and I’d wager helping the universities get money from SV in return for hiring/promoting anti-patent faculty.
I can’t believe this nonsense of prophetic examples being attempted to be pushed into the CS/EE/mechanical fields.
Try actually looking at how people in these fields work and the way they think.
Textbooks say that functional language is meant to capture known solutions.
We know all those solutions. We can list literally 10’s of thousands of different ways to solve the same problem and are only interested in what is new.
Y U C K ! The ignorant mob is at the doors at again (I hear the Tarantula trying to tear down the walls of intellectual integrity.)
The ignorance from these 112 arguments is just stunning. We have people that couldn’t understand a Turing Machine if their life depended on it trying to tell us how a POSIT thinks about CS/EE/mechanical inventions.
Just absurd. Defund the CAFC.
“Defund the CAFC.”
Now that’s one defunding plenty of stakeholders can get behind.
I do not understand the uproar here, over what is called “prophetic” examples. Comment please.
Since the dawn of patent time, Applicants and their drafters have been creative in writing “Examples” for inclusion in their patent application specifications. Understood in the courts of England, again since the dawn of patent time, is that Applicant thereby takes a calculated risk in making such a delivery of an apparently enabling disclosure that is commensurate with the full width of the claim.
What else should an ordinary Applicant do though, when there is not enough time (or money) to perform worked examples all over the scope of the claim, even before generating a filing date at the PTO? Perhaps rely on the (again, as old as the hills) line of case law that decrees that “one way is enough”?
So, either the Examples turn out in time to “work” or they don’t. If they do, enablement is not in question. If they don’t, you’re going to have a problem with enablement.
Which is one reason why the PTO, ex Parte, is ill-equipped to assess the “quality” of any given patent application. Full-blown disputed, inter Partes proceedings are needed.
Tell that to the concerned senators, somebody, please.
Its not the concerned senators that need to be told not to include things that they have not yet done.
You seem to want to make light of a practice of claiming more than invented with this thin reed of “oh well, if it does not actually work, I may have an enablement issue”
Are your inventors required to take an oath?
Also – I find your response (here) to be more than a bit disingenuous, given Greg’s responses to you…
see at least link to patentlyo.com
… concerning mischaracterization of future items as items that HAVE been completed.
This is not a small ‘oopsie.’
This hearing ends up beind held the same week as a Federal Circuit panel in Amgen v. Sanofi encourages the use of prophetic examples to enable claims…
To be fair, it was only Judge Lourie’s concurrence, not a “panel” of the CAFC. Also what is wrong with prophetic examples?
It was the same panel that decided Amgen and the opinion was for three judges. Nothing wrong with prophetic examples – just some tension between the opinion and the testimony discussed in this post.
Here (and elsewhere), the Big Pharma shill Greg is ‘all of a sudden’ NOT concerned with 112 issues of which Pharma routinely partakes…
No one could see that coming.
Greg, as you are in the business of “prophetic” examples, do me a favour, will you. I do understand that Applicant uses them at their own risk: if they turn out to be inoperative, there might be an enablement problem. But how is the USPTO supposed to check out enablement and then issue a patent that in the courts enjoys a high presumption of validity precisely because its content has been rigorously examined for compliance with all the conditions of patentability?
I mean, what is to stop an unscrupulous non-American Applicant getting the USPTO to issue problematic claims by the skilful use of plenty of “prophetic” examples? Or, in the context of low quality patents, is this just not a problem?
“if they turn out to be inoperative”
MaxDrei, do you mean like so much of the Big Pharma wash-outs during FDA examination that shows a lack of possession of utility (because that utility “turns out” not to be there)?
Does not this incriminate most all Pharma apps that do such, given that patent law requires possession AT the time of filing?
Cue the case law quote on “we do not give patents for study plans”…
The “utility” required to secure FDA approval is not the same as any utility needed for patentability.
I would suggest that the problem of “low quality” patents which is troubling the senators is less pressing in the field of pharmaceuticals than it is in, say, do it on the internet-type claims.
The “utility” IS the same as claimed.
Just because the FDA is testing for something (putatively under strict standards) does NOT change what claims are intended to cover.
Venture down your path and you end up squarely with any FDA approved Pharma item NOT being what is presented in patents asserted to cover those products.
You really do NOT want to go there, now do you?
Anon – no.
The “utility” of a molecule does not rest solely on its usefulness as a human pharmaceutical.
Novel, nonobviousness molecules are patentable in the U.S. regardless of future success or failure in a clinical trial. These same molecules may remain useful after a clinical failure for other purposes or even other indications in humans.
Sure, certain methods of treatment claims should remain unpatentable if the method of treatment doesn’t work – but that’s different than the composition claim.
Nine times out of ten, the following is simply NOT true:
“These same molecules may remain useful after a clinical failure for other purposes or even other indications in humans.”
And certainly not true for the applications as filed.
Pharma gets a HUGE pass because of “human health.”
Novel non obvious molecules are NOT patentable merely because a molecule is novel and non obvious.
If your application as filed is aimed for non-human utility — that is one thing. But clearly we both know that we are not talking about patents aimed at non-human Pharma inventions.
As I stated: Venture down your path and you end up squarely with any FDA approved Pharma item NOT being what is presented in patents asserted to cover those products.
The phrase “prophetic example” covers a lot of territory. The value of any given prophetic example is very context specific.
Imagine in scenario (1) that I discover a new technique in organic synthesis that makes it possible to synthesize compounds that have never before been made. I make a few such compounds and show that they are effective antidiuretics. I disclose these compounds, the exact synthesis schema I used to make them, and the test data confirming their utility as antidiuretics. I also disclose (in the future tense) synthesis schema for other specific compounds that I have not reduced to actual practice.
Here, one of skill should presume that the prophetic examples will work in the same manner as the bona fide examples. The prophetic examples constitute written description support that entitle me to claim the prophetic species. An examiner who objects to the prophetic species is being unreasonable, because the schema I am describing prophetically are just variations on a theme that I have shown empirically to work as claimed.
In scenario (2), my entire disclosure is prophetic. I do not reduce a single species to actual practice. In that case, an examiner the examiner is quite justified to call enablement into question. Under In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977), the examiner would be completely justified in rejecting the claims for lack of enablement unless and until the applicant actually runs the experiments whose procedures are described prophetically, and shows the data in a Rule 132 declaration (i.e., under penalty of perjury). Of course, if the applicant does run the experiment post-filing and it works as the applicant has prophesied, that means that the application is enabled as of its filing date, because the results of the experiment are inherent in the description of the experimental procedure.
In other words, some prophetic examples are worth more than others in the enablement analysis. An examiner must simply use good sense and scientific judgment in deciding how much credibility to accord to any given prophetic example.
Thanks Greg. As I said, this is not my field. So I read with some surprise about your care to distinguish prophetic examples from worked examples by using for them the future tense. I hadn’t realised that. I had supposed that all examples are presented in the same tense, regardless whether their data comes out of a lab or out of the head of a researcher.
So what if the drafter includes lots of Examples but eschews the future tense. I had supposed that this was routine, endemic (at least, outside the USA) since more or less the dawn of pharma patent time. In such a case, when there is no need to call for a Rule 132 Declaration, what does the Examiner do, other than issue the patent, with all the consequences that follow?
But as I just wrote in another blog, the problem of “low quality patents” is certainly more pressing outside the pharma space than inside it, so in a nutshell, who cares about whether the examples are prophetic or not?
It is super important (at least in the U.S.) that prophetic examples be in the present or future tense, while actual reductions to practice should be described in the past tense. To use the past tense for a prophetic example is inequitable conduct, because it is considered a representation to the USPTO that one had made an actual reduction to practice. Apotex v. UCB, 763 F.3d 1354, 1359 (Fed. Cir. 2014).
If the examiner issues a patent (in other words, concluding that the claims are properly enabled) because the applicant described prophetic examples in the past tense, that granted patent will be unenforceable for inequitable conduct.
MaxDrei –
In my practice, we only include prophetic examples that are actual planned experiments, and we only include them so that the data can easily be brought in at a later date. Often the one year post-provisional is not long enough for clinical trial or long-term animal data to be available after a molecule is invented.
So a question (which I know the answer to):
Why don’t you wait until you actually know that you possess the invention?
We all know why this question remains unanswered.
lol – song and dance when a Pharma ‘trick’ wanders into the spotlight…
“As I said, this is not my field”
funny then how you jump to defend it and want the focus switched to non-Pharma, eh?
I worked in the private sector for 30 years. I now work at the USPTO. Anyone on this thread who says the Office is run by hacks is wrong. The management team is incredible: hard working, thoughtful, engaged daily in every issue discussed within the patent bar, in the courts, in Congress, and in the IP community. Anyone who criticizes USPTO examiners for being slothful incompetents has likely never met one. The vast majority of these professionals take their jobs seriously. They understand the implications of their decisions on individuals, on organizations, and on nations. They work directly with those who submit applications through e-mail and personal, one-on-one discussions over the phone. The amount of highly technical prior art that exists in the world in dozens of foreign languages is incomprehensible, and they have to find all of it. That doesn’t happen with a Google search. Moreover, the examiners’ names are on the patents they approve. That is a big deal, and says a lot about examiner accountability. For those of you who are intent on trying to degrade or destroy one of our great institutions, please stop. We are incredibly fortunate to have such dedicated civil servants (and political appointees) doing what they think is best for inventors, entrepreneurs, for our country, and for billions of people who benefit from our IP system in every nation.
I’d say 80 percent aren’t too far from your characterization.
Want to improve quality? Go back to TSM and dump 101. 101 consumes a lot of wasteful time and TSM is what the standard should be and it is something that can be QR’ed.
“Want to improve quality? Go back to TSM and dump 101.”
Because when people think 2006 patents, they think quality!
Mr. Strawman Ben, do you think 2006 patents were of a lower quality than 2021 patents?
I think there was a lot of ground breaking technology happening from 1995-2005.
The quality dropped because of the creation of PTAB. It took the pressure off the PTO to issue high quality patents because the lower bar will be disposed of by the PTAB. Plus the PTAB now needs something to do, so let’s keep full employment at the agency. It’s public choice theory right in front of everyone’s nose. Can’t understand how the smart set has any difficulty see it.
smh…
enabled by a captured Congress, who did not bother having any type of feedback or closed-loop mechanism (while still claiming ‘This improves quality’) from the post grant left hand taking away what the examining right hand gives.
You are absolutely correct in that it is the Office that captures fees from both ends of this arrangement.
Funny too, how Greg “I Use My Real Name” DeLassus was always so big in the Oil States discussions to emphasize that (the full combined term of) Public Franchise was a form of personal property, but simply refused to venture into any deeper aspects of what such a “Franchise” structure might entail (for example, duties of a FranchisOR to a FranchisEE).
“do you think 2006 patents were of a lower quality than 2021 patents?”
On average, yes.
I suspect that if TSM had never been invented by the CAFC, and a looser obviousness standard had ruled in the late 90s and early 00s, we never would have had Alice.
NW, how do you propose to make TSM mandatory without directly violating KSR?
It is a good question Paul.
I think what the PTO could do is demand the examiners find a TSM for rejection and then if they can’t find a TSM, use as a fallback KSR. The examiner gets docked if there is a TSM and KSR was used. The examiner gets a docked if they allow and there is a TSM.
What I know is that TSM is something that can be QR’ed whereas KSR is almost impossible to QR.
Anyway, the key is that TSM is something that can be QR’ed and something that can be outsourced. KSR is mushy nonsense.
How is this to be implemented? Will only a small number of actions be reviewed as is the current practice, or will you be increasing fees to more thoroughly review examiner work product? For what it’s worth, I’d applaud a fee increase that meaningfully increased review of work product, but I doubt your colleagues would.
‘Will only a small number of actions be reviewed as is the current practice,”
Hmm seems an interesting ‘thread’ to tug on… (a la SAWS)
Do applicants currently “pay for” such a delightful choice, and how (exactly) is that “small number” chosen?
Are these deliberations in writing (you know, in order to comply with 37 cfr 1.2)?
There must be two USPTOs.
That was my response to InventTheFuture.
Is this examiner one of those dedicated civil servants?
link to drive.google.com
Seems so. Everyone involved in that case is failing upwards lol. You know, except for the applicant who is paying.
“The management team is incredible: hard working, thoughtful, engaged daily in every issue discussed within the patent bar, in the courts, in Congress, and in the IP community.”
They can be perfectly charming and dedicated to the tasks that interest them, and still be hacks, if they carefully choose to avoid looking at the broken core of the PTO: the count system.
To be fair, the most recent management did look at the count system, and they apparently liked what they saw. They worked hard to pile up absurdities to buttress the count system for the next 50 years of examiner and applicant misery.
Let look at management’s recent work product.
One of absurdities they’re duct-taping to the old count system is how to calculate the expectancy time from a mix of technologies. They decided to average technological difficulties to determine expectancy times.
Hard technology + Easy technology = Medium difficulty Technology.
That is simply ridiculous. Examining a hard technology does not become easier when you mix a little of an easy technology into it. This is their work product, it is bad, and they should be judged for producing bad policy.
Each case should be assigned its own expectancy based on, inter alia, 1) the length of the application; 2) the number of claims; 3) the number of references (and the length of those references) that must be searched based on the classification of the application (some of remember that being called “the mandatory search”); and 4) the average IDS(es) submitted in that art. The PTO has the data on all of these factors.
That wouldn’t be perfect, but it would more accurately reflect the amount of time it takes to read the application, search the application, read the most pertinent references, and write an OA that addresses the claims, better than the current count system (examiner PAP).
That sound likely to be an improvement. It certainly sounds like a good faith effort at improvement.
But saying “semiconductors + rubber duckies” takes less time to examine than just “semiconductors” is plain-as-day indefensibly wrong. That is what our “incredible: hard working, thoughtful, engaged” management has embraced.
The vast majority of the “managers” at the PTO got their jobs by cranking out production. That’s all they know. How to work the count system. I’ve dealt with a few that were hard working, thoughtful, and engaged. But they are a relatively small minority of the useless GS-15 class.
“The vast majority of the “managers” at the PTO got their jobs by cranking out production. That’s all they know. How to work the count system.”
This is truth. But it’s also a result of this count system factory style setup that mgmt has in place, so, working as intended I guess.
Pure B$
Many types of industries have “widget factory” mentalities and do NOT suffer from the conditions at the USPTO.
Oh wait, you don’t have experience out in the real world to know that.
“Many types of industries have “widget factory” mentalities”
Uh yeah but many industries are widget factories. In which case that mentality probably wouldn’t plague that industry with the very specialized “peculiar issues” that “plague” patents a bit.
“Oh wait, you don’t have experience out in the real world to know that.”
You keep saying that but I have 10 yrs exp working outside the office. It’s just factually incorrect.
You missed the point of being widget factories, as even those do not suffer from the (excuse) that you want to offer for the Office.
You must have had some seriously sheltered position in that decade of “real world” experience (or have been so mind-F’ed by your Office experience)….
” even those do not suffer from the (excuse)”
Nobody suffers from excuses anon, not those industries and not the office.
“and write an OA that addresses the claims”
Toss the length of the OA that ultimately results into the mix and you’re getting closer to what needs doin.
Unfortunately too many examiners mistake the length (quantity) for the quality of the OA. I frequently receive OA’s with a page and a half of form paragraphs about how terms will invoke 112(f) and then never state that any of the claim terms invoke 112(f). What is the point of that? Just making the OA longer to make it look like it’s better “quality”?
Get.To.The.Point.
With all the automation tools out there why isn’t there a better OA writing program? Why can’t the PTO have an OA writing program that inserts claim charts for the claims? So all the examiner has to do is fill in the right side of the claim chart with the cites to the reference(s)? Just looking at the forms on the PTO website that they expect us practitioners to fill out makes me say, “why do all of these suxx so much?” Why do all the tools, for examiners and applicants, that the PTO provides suxx so much?
Maybe you examiners need to start agitating as well.
“why isn’t there a better OA writing program?”
…because the Office would not allow a patent on it….?
(too close to Night Writer’s example of what judges do, perhaps)
“I frequently receive OA’s with a page and a half of form paragraphs about how terms will invoke 112(f) and then never state that any of the claim terms invoke 112(f). What is the point of that?”
I think the point may be to follow training. Awhile back there was some 112f training about some new form paragraphs, and I believe one long paragraph in particular was basically just a reminder for applicants that 112f existed. I guess the OPLA folks were looking for something to do after they perfected the clarity of MPEP2181.
All of the form paragraphs that just contain cut and paste sections of the MPEP need to be edited to, “See MPEP…”
I don’t need the MPEP in the OA.
At least 50% of what I see in OA’s could be deleted.
B-b-b-it cut and paste is ‘the hard.’
/s
“Follow training” — in a mindless and unheeding manner — should be penalized and not used as an excuse.
“Unfortunately too many examiners mistake the length (quantity) for the quality of the OA.”
They make us write it in this long ass fashion. I could write most rejections in like 4 lines for each claim and it would suffice for 95%+ of the people reading my actions. That last 5% of attorneys that aren’t really big in exp in my area tho they would perhaps be left behind a bit.
“What is the point of that?”
Never seen it myself.
“With all the automation tools out there why isn’t there a better OA writing program?”
Currently the office has what it likes I do believe. There actually are ways to do some overall setup of the OAs just having the sections setup in a template, but that doesn’t much help all that much overall in my experience. The part of writing OAs up that takes so long is usually a. finding all the citations and filling them in one at a time, and b. setting up 103’s perfectly and c. just finding facts from the refs (maybe you could call this separate but whichever). Esp with the refs getting longer and more complex, on occasion more vague, or maybe not vague, hard to tell sometimes (as we saw with your example you posted the other day where you had 2x embs setting forth substrates, implicitly being single crystal and glass respectively, and then another emb just after those embs where they just go ahead and say use any suitable substrate, are they referring to the two previous examples in that context, hmmmm, hard to say, and does the disclosure of Si subs in general necessarily disclose the three major types of amorph/poly/single, or at the least the biggie single, to one of ordinary skill reading such ref, hmmmm, hard to say).
“Why can’t the PTO have an OA writing program that inserts claim charts for the claims?”
Would be nice, but that’s not the biggest issue in writing OAs as I noted above.
“Just looking at the forms on the PTO website that they expect us practitioners to fill out makes me say, “why do all of these suxx so much?” Why do all the tools, for examiners and applicants, that the PTO provides suxx so much?”
Tbh I would presume that they are trying to do 2 things. A. use the writing of the OA to force the examiner to consider the claim’s language to the maximum extent possible (a sort of quality control that does exist and does sometimes work), B. make it be encouraged for the examiners to explain their position in the rejection.
and where was your union protection during this…?
(rhetorical, eh 6?)
Not even rhetorical, they were in the little closet that serves as their office lol.