by Dennis Crouch
Although this case comes from an inter partes review, it is one that could be used by patent prosecutors when discussing claim meaning with examiners. The basic principle here is that the “broadest reasonable interpretation” of a claim must be considered “in light of the specification.” Here, the claims did not spell-out a sizing limitation for an artificial heart valve, but the size was apparent from the specification.
St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020)
I feel really bad about this, but whenever I see a Snyders lawsuit, I cant stop thinking back to the late 1990’s when I used to eat Snyder’s mustard flavored pretzels.
This case is not about pretzels, but rather focuses on Snyders artificial heart valve patent US6540782. Eat your heart out?
Snyders sued St. Jude for infringement in D.Minn and St. Jude responded with a pair of inter partes review (IPR) petitions. The PTAB initiated the IPRs and eventually ruled that some of the claims were anticipated by a prior patent.
- IPR2018-00105: PTAB sided fully with the patentee on obviousness and anticipation challenges based upon Leonhardt
- IPR2018-00106: PTAB sided partially with the challenger — finding claims 1, 2, 6, and 8 anticipated by the Bessler patent, but finding the remaining claims patentable.
Both parties appealed, and the Federal Circuit has fully sided with the patentee Snyders.
The focus of the appeal was on construction of the following claim term
… a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region…
Basically, the artificial valve includes a bendable frame that will fit in the natural valve position. It also includes attachment hooks to hold it in place.
An important aspect of Snyders valve is that it can be inserted into place without removing the native damaged valve. The key prior art (Bessler) also disclosed a valve insert, but it was sized to fit the valve location after removal of the damaged valve. The problem for Snyders is that the claim language does not make this distinction explicit. Rather, the claim only requires that the frame fit in the position between the upstream and downstream regions (i.e., the original valve location). Thus, the PTAB broadly interpreted the claim language to also cover a frame “sized and shaped” to fit in the location after removal of damaged heart material.
On appeal, the Federal Circuit reversed the claim construction — holding that sized to the native-valve-space should be read into the claim, even when applying the broadest reasonable interpretation:
The claim’s reference to “repairing a damaged heart valve,” without any reference to removal, suggests that the native valve remains. So too does the claim’s reference to the damaged heart valve “having a plurality of cusps,” which appears superfluous if claim 1 is interpreted to include embodiments where the damaged valve and its cusps are removed. . . .
The specification states that “the frame is sized and shaped for insertion between the plurality of cusps C of the damaged heart valve in a position between an upstream region and a downstream region.” . . . Moreover, the specification stresses that the artificial heart valve it discloses can be inserted without removing the native valve and that this is an improvement on the prior art.
Slip Op. The specification actually particularly references Bessler as problematic prior art that requires “removal of the native valve, cardiopulmonary bypass and
backflushing of the coronary arterial tree.” Snyders explains that its approach avoids those major procedures.
Finding of anticipation reversed. Now the case will go back to Minnesota to consider infringement and perhaps other invalidity arguments.
Get rid of ‘legal claims’ and lawyers altogether! Go back to ‘letters patents’ that can be submitted – for free – by inventors of any ‘class’ or socioeconomic standing! They were good enough for a long time and brought us the industrial revolution and great prosperity!
Make patents more like they used to be – more like copyrights and far more easy for ‘ordinary people’ to understand (not just lawyers who never agree with each other)! Make the ‘teachings’ in patents, those that are decided to be ‘novel’, ‘useful’ and ‘significant’, by a majority of experts in each field.
Patents used to be fairly easy to understand and agree on, as to what an inventor disclosed, taught and (technically) claimed, rather than what examiners and attorneys TOLD THEM they invented and could (legally) claim! Science and invention have NOTHING to do with human laws! Science and invention does not require ‘permission from any court’, in order to exist, be valid, be documented and be understood by the public – even if they may not be experts in a field!
Patent disclosures should only be ‘interpreted’ by experts in each field, to determine what has been adequately disclosed and what is truly new, novel and/or significant! They are the only ones having the deep knowledge and scholarship needed to do this! In the same way Nobel Prizes are awarded in specific fields (based entirely on merit – not legalize), so should patents be awarded and IP rights protected! Lawyers & judges are never asked to decide who should and should not get a Nobel Prize, are they? They are never asked to decide who should or should not get a million dollar prize, as a reward for their valuable contributions to society, are they?
I’m therefore arguing that (potentially very valuable) patents should be awarded based on the same (or at least similar) criteria that the Nobel Prize committee uses to make their awards, particularly in the case of adjudicating ‘who invented what and when’ and whether what was invented was of at least ‘some novelty and benefit to society’! Let’s adopt similar – objective & scientific – standards and procedures for also deciding questions of infringement! And, while we’re at it, we also now need laws prohibiting and punishing ‘plagiarism’ as well (especially the plagiarism of original ideas). No one should be able to profit from the original ideas of others!
As to what ‘original’ (and non-obvious) means – that too should be a question for ‘true experts’ in the field, not lawyers or the courts! That is NOT a legal question – that’s a scientific, historical and societal question. Even the courts can’t re-write historical fact and inventors should be protected from any attempts to re-write the history of innovation and invention! Whoever historically invents or teaches something new, IS THE FIRST INVENTOR of that new teaching or invention! The courts cannot change that and attorneys should support such protecting against the re-writing history (if innovation is to continue and be appropriately and fairly rewarded)!
To anyone opposed to the fair compensation of our nation’s inventors (especially non-corporate inventors), do we have so many inventors now that we can ‘extravagantly afford’ to just SCREW THEM ALL, by any means necessary, including via court mandates to do so? Should America’s inventors get repeatedly (and inevitably) cheated, just because our courts may say its perfectly OK to do that – as often as desired?! What kind of an ‘innovation policy’ is THAT?
Just because if you are persistent enough, you can ‘legally cheat’ almost any inventor in America (unless they work for a powerful corporation), doesn’t mean we, as a society, should allow doing that! There used to be something called a ‘social contract’ between innovators and society – what happened to it and who’s to blame for it no longer be honored in America? That’s a question to you, Director Iancu (and Congress)! Inventors of America UNITE and demand better!
The USPTO checks all the boxes required to be declared a ‘lottery’, rather than a legitimate ‘game of skill’! I will let the lawyers out there ponder the potential significance and ramifications of this (mathematically provable) observation, assertion and conclusion. And when the fact that lotteries are illegal in all 50 states, unless specifically authorized by each of the 50 state legislatures, the implications of this could truly be ENORMOUS and have equally enormous consequences (including retroactively), since it would call into question the very constitutionally of all that the USPTO does no, without having the express authority of Congress or the individual states to do so! None of these legislative bodies would ever approve of using a LOTTERY to decide matters of such great importance and consequence to the U.S. economy and individual rights to earn a living – as an inventor!
Patents cannot be granted through an ”IP lottery’ – period! Not even initially (say, pending appeal)! That’s NOT how the Founders intended this to be done! That’s NOT how Congress intended this to be done (, Director Iancu)!
So, anyone care to join us in a future class action intended to decide this question (on behalf of all American inventors)?
George Sachs
President & CTO
Paradyme Systems USA
It’s not really “broadest in light of the specification”; there is more, since a patent spec is directed to the person of ordinary skill in the art. In this instance, the persons of ordinary skill are cardiac surgeons, and the skill level is high. So the issue re interpretation isn’t broadest in view of the spec, it is broadest in view of the spec in the mind of a surgeon who has read and understood the spec. The opinions of non-surgeons regarding what the spec teaches the posita should be given a hefty dose of scrutiny, and possibly ignored or dismissed. Remember, the spec need not teach and preferably omits that which is well known to the posita, and what these surgeons carry around in their heads is more than casual observers understand. Absent knowing the contents of the mind of the posita, those not a posita are unfit to opine.
Nice post.
But that’s obviously NOT how things are done now (maybe they were in the distant past, with ‘letters patents’, but not anymore)! We should return to have ‘experts’ decide what an inventor meant and communicated to the public, a POSITA, AND/OR experts in the field. The latter being the only ones that can truly and objectively decide what ‘new’ has and hasn’t been taught by an inventor, whether the inventor was an expert or not.
Just as in the past, it should be up to true and CONTEMPORARY ‘experts’ in the field to decide such matters in light of historical knowledge that goes far beyond previously issued patents. That, or we should go back to requiring proof of functioning as claimed as in the past (i.e. with models, or pictures, or videos or now computer models).
Requiring proof of ‘enablement’ would clear up a whole lot of disputes and would have prevented Theranos and Elizabeth Holmes from getting most of their patents! She would then have been identified as just a fraud early enough to prevent investors from losing $800M!
Oh, and panel of Newman, O’Malley and Taranto, but again, DC refuses to list the panel composition when he reports cases. Only suprise here is that Taranto got on board with the other two judges (he authored the decision).
Dennis, there apparently IS an IP issue lurking in the background of Snyder’s of Hanover,: in small print on SOH’s packages there appears a statement that reads something like “Snyder’s of Hanover is not associated with Snyder’s of Berlin”. Maybe you or one of your students can do some digging into this and enlighten us.
@MaxDrei
” The test in England is “What would the skilled person understand the language of the claim to mean”. Gets you to the same result, no?”
Not with a different Examiner (or even the same one 2-3 years later)!!! Admit it, there is NO consistency in the examination process, a PTAB review, or a Circuit Court review! Is THAT how things should work in patent law?! Is that how anything should work?? What if a death penalty were involved? What if $1M dollars were involved?! $100M???
Shouldn’t the goal ALWAYS BE be to get things 100% right from the start?! Would you want to buy a car (with 1000 parts), that has a 50/50 chance of even working – with no refunds allowed??? That’s basically how our PTO works now! No real ‘quality controls’ (to ensure consistent results and no guarantees whatsoever – regardless of how much you pay them!!!Some inventors have even shelled out $100K (including court actions), getting nothing in return!!! That’s NOT acceptable Congress!!! That’s just NOT acceptable!!! That could be a person’s life savings!!! That would be like someone going to Vegas and losing $100K there!
Inventors don’t want to be gamblers! Independent inventors and small entities shouldn’t be FORCED to become big-time gamblers, just to get a patent! The Founders clearly didn’t want that!!! Inventors should get treated a LOT better than that! In fact, the government should be subsidizing at least some of them (the most talented ones) and paying all their filing fees too (or charging them nothing to get a patent). American inventors should be treated as valued intellectual and information ‘resources’, not ‘nuisances’ to big companies (the way they are now)!!!
Mark, et al.
Why weren’t ANY of Theranos’s 160 patents ever denied issuance? Why were they all just ‘rubber stamped’? Why did every one of them have Elizabeth Holmes’ name on them (even though she wasn’t an inventor on maybe any of them)?!!! This company and Holmes were complete frauds!!! Why did that happen? Who at the PTO ‘greased the wheels’ to make that happen in less than 5 years?! We never get a patent in less than 5 years now!!!
Why hasn’t the USPTO launched an investigation into that part of the Theranos fraud scandal? Something doesn’t smell right there and needs to be investigated by the FBI, Congress or the AG’s office! This couldn’t have happened by accident or due to merit!!! The Examiners of all those patents and their supervisors need to answer some tough questions now, and if they were in on the fraud, then an example needs to be made of them, so it doesn’t happen again!!! Also, Elizabeth Holmes needs to also be charged with 160 counts of violating the felony crime of lying on a patent application oath, under 18 U.S. Code § 1001. That has a penalty of up to 5 years in jail for each count! 5 x 160 = 800 YEARS! LOL!
Also, why do the top 500 companies easily get their patents approved in typically less than 3 years (often in 18 months), while most individuals & small entities almost never do (even when represented by large law firms)??? Why is that? Why is pendancy for large corporations less than 2.5 years on average, while it’s much more than that for others? Why do big companies never seem to have to file continuations? Why do others need 2-4 or more, if they want a patent?
Why do big companies almost never have to file appeals? Are big companies favored over small ones (maybe because they pay the PTO a lot more and examiners know who butters their bread)? All of this needs to be investigated by Congress and if the process needs changing – they better do it fast – and some heads should also roll! Otherwise China will definitely eat out lunch!
We may be losing 1000’s of great inventions and billions of dollars worth of technology every year, just because the PTO denies talented inventors the patents they deserve and makes it nearly impossible to defend any patents they might get (while lawyers get rich anyway)?! Doesn’t this just make it trivial for China and others to use and sell products based on those published inventions, for free? Aren’t we just giving away IP belonging to hard working American inventors? Isn’t the PTO just deliberately ‘screwing’ American inventors now, rather than protecting them?
Within a decade, we may have no more independent inventors. They could all become EXTINCT because the social contract that existed for 200 years, has now been completely broken, and so inventors might be much better off keeping their ideas secret (until they can actually develop them) and going to Vegas with that spare $20K they might otherwise WASTE on lawyers. They’d also have a lot more fun doing that, than fighting with or begging the PTO for a ‘good’ and ‘enforceable’ patent (that they’ll probably never get anyway)!
Our patent system has now become a very expensive and very unfair CON GAME, that tricks inventors into publishing and making public their (formerly trade secret) inventions, whether or not they ever get a patent! That is just NUTS and didn’t used to happen! That violates the social contract that existed for 200 years and was always supposed to exist between inventors and the government!
In fact it can now be PROVEN (by us or anyone) that our patent laws and their implementation are effectively just a ‘lottery’ (for most applicant’s) but one ‘rigged’ in favor of the largest companies and monopolies, who heavily lobbied for and paid for the AIA (with support from a majority of lawyers). This can be EASILY be proven now – using the PTO’s own data! The AIA has clearly RUINED our once ‘unique’ and great patent system – the one that made Tesla want to come here. He would never have wanted to come here today, because he would have known that his inventions would just get ripped off here!
Slightly different comment. Why can’t this case be resolved based on whether St. Jude is using the prior art or whether they are using Snyders’ technology? Claim construction is being abused to create a controversy where there is no controversy. The name of the game is the game of gaming the words in the claim. The game is played by lawyers and bureaucrats and infringers – it has nothing to do with innovation.
St. Jude can use the Bessler technology, but they should get permission from Snyders if they want to use theirs. All this arguing about claim construction is unnecessary – unless Snyders sued St. Judge for using the Bessler technology.
Agree!!! It’s all become just a giant ‘scam’ now (greatly favoring large corporations) and we may try to ‘prove this’ in court soon!
It’s become a huge (and ridiculously expensive) ‘lottery’ – not a true ‘game of skill’ where the most talented and accomplished win! There are laws against lotteries in all 50 states and Congress has never approved of an ‘IP lottery’ anyway! They probably wouldn’t be pleased to learn that the USPTO is being run like one, now!!! The PTO’s own data can easily prove that!
Why don’t they construe the claims to cover what was invented?
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.” (35 U.S.C. 112(b))
It is the responsibility of the applicant to be his/her/their own lexicographer and set out claims clearly defining the scope and content of the invention. Claims were first required by the Patent Act of 1836. At first, “central” claiming was the norm, where the claims simply set forth the gist of the invention and the courts themselves determined the actual limits of a claim’s scope. “Peripheral” or “meets-and-bounds” claiming was required beginning with the Patent Act of 1870, using the current “distinctly claiming” language. However, a faint relic of the old central claiming system still remains (albeit on life-support) with the “doctrine of equivalents” per Graver Tank; limited by Warner Jenkinson, and Festo.
I know. That is what we do when we apply for and prosecuted a patent. Then it is granted. Why don’t they construe the claims in an issued patent to cover what was invented? It is nonsensical to construe them to cover the prior art.
Ah, I think I see what you mean. You want to know why there are two different standards of claim interpretation in first place. So, during a patent application’s pendency – while claims can still be amended – any potential ambiguities are resolved in favor of the reasonable interpretation with the most breadth. (Breadth of scope is the default at that point.) If it is too broad so that it covers prior art, the Examiner will cite that prior art and reject the claims. It is the responsibility of the applicant to amend the claims such that (and until) they can’t reasonably be interpreted as covering (known) prior art. This serves the public interest, so that the granted patent claims are clearly and unambiguously distinguished over all prior art of record (and combinations thereof). The BRI standard is the PTO’s leverage toward ensuring the grant of patentably distinct claims.
Of course, once the patent is granted, further changes to the claims are time consuming and expensive (reissue, reexamination, etc.). The presumption of validity and the plain meaning of the granted claim terminology to those in the pertinent art then governs their interpretation.
But in every case, it is the applicant who is the one responsible for defining what is regarded as his/her/their invention and for giving proper notice to everyone else through claims with predictable scope and meaning. If they are still too broad at that point, those claims will be invalid for covering prior art. No patent owner wants that to happen, so the BRI standard during patent application prosecution also serves them well to minimize the possibility of an invalid patent.
No, I am asking why an issued patent construed under the Phillips standard is not construed to cover what was invented, rather than the prior art. Particularly when the patentee affirmatively disputes and disclaims the broader meaning (still under Phillips).
Another way of asking the question, is why don’t courts (especially the PTAB) follow Phillips in construing ambiguous terms to uphold validity of the patent?
“why don’t courts (especially the PTAB) follow Phillips in construing ambiguous terms to uphold validity of the patent?”
But . . . but . . . but . . . if they did that, the PTAB might have to return their Official Death Squad Certificates (suitable for framing!), badges, and pins!
Better yet, why not let an unbiased panel of experts in each particular field decide what the inventor meant by his writtings and teachings, and whether or not anything really new or significant has been contributed to existing knowledge?! It’s as simple as that. If they conclude ‘there is nothing new here’ or ‘he can’t claim ALL that because others have already done some of it’, then that should be the final word on the subject!
Because that’s not how the game is played (by lawyers and examiners).
What should be done if there is confusion about what claims taken together with the specification mean, is to convene a panel of experts in that particular field to come to a consensus, rather than having lawyers and judges try to do that. Who else would know more about is and is not original and significant in any highly specialized field. Lawyers can’t do that. A lay jury certainly can’t do that!
It may be helpful to remember that the “broadest reasonable interpretation” standard derives historically from the fact that a patent applicant still has an opportunity to amend the claims to address any interpretation issues of breadth or clarity raised by a patent examiner. It is not simply a matter of the PTO applying one standard and the courts another.
In an IPR of a patent, such opportunity is limited. A patent owner may file one (and only one) motion to amend the challenged patent claims, subject to the standards and procedures set by the Office, during an inter partes review. Amendments may cancel any challenged patent claim and/or propose a reasonable number of substitute claims. As such, the applicability of the “broadest reasonable interpretation” standard in IPRs, at least after opportunity for amendment has been exhausted, is open to debate. Fortunately for the patent owner in this case, Snyders got the interpretation it wanted despite applying of the BRI standard.
What a good point. It reminds me that under the EPC the issue of clarity of claiming (ie definiteness) is not justiciable once the patent grants. The consequence (of course) is that the EPO is red hot on issues of “clarity” when examining prior to issue.
This seems like a pragmatic arrangement. Likewise, it seems to me reasonable for the USPTO to be, prior to issue, keen on exerting its BRI lever, to the benefit of not only the Applicant but also the general public.
Further to my previous comment, it has come to my recollection that the PTO had changed their standard of interpretation in post-grant cases. After checking, I confirm that for IPRs, 37 CFR 42.100 has been amended to construe the claims “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent”, which is the Phillips standard used by the courts. However, this change only applies to cases filed on or after November 13, 2018, not already pending cases, so Snyders fell under the older BRI interpretation.
It is perhaps also debatable whether the two standards yield different interpretation results in practice. Any thoughts?
Mark, thanks for the cite to amended 37 CFR 42.100 changing claim interpretation in IPRs filed after 11/13/18 from BRI to In re Phillips (en banc). [Thus IPRs on BRI not yet decided by the Fed. Cir. should end soon.]
B-b-b-but “sized and shaped” are functional (and merely desired results) claim elements….
That’s a 112 argument, that was not addressed here and will be by the district court…
If heart valves come in all sizes, then saying “sized to be inserted into another valve” is likely indefinite. (Its like saying “pants sized to fit a wearer.” The same pair of pants would infringe if Shakira were the wearer but not infringe if Luciano Pavarotti were the wearer… Thus you cant just look at a pair of pants and say whether they infringe or not)….
It won’t matter to an Examiner who has decided that BRI = Broadest Reasonable (or unReasonable) Interpretation. Individual cases like this don’t have any impact on the PTO. Doubt me? Try citing this case in your next response and watch the examiner respond with citations to the MPEP that include caselaw from 1970.
Good observation. It’s just the same at the EPO, where citation of persuasive case law, bang up to date, is met with reliance upon the “Guidelines for Examination”, the “holy book” for Examiners at the EPO. In reality, what choice do they have?
Mind you, at the EPO, the case law doesn’t go back as far as 1970. Back then, the EPC was no more than a gleam in somebody’s eye.
Seems to me eminently sensible. The test in England is “What would the skilled person understand the language of the claim to mean”. Gets you to the same result, no?
Who thinks the Fed Ct got it wrong?
The issue now is that the claim refers to something external to the claim– “A valve sized and shaped to be inserted into another valve [that is not recited in the claim].” Unless other heart valves all have particular sizes known to one of skill in the art, it should come back for a 112 indefinite rejection.
Indeed. Reference to an object external to the claim is often problematic. But every case should be decided on its facts, I would say.
Heart size varies from person to person, child to adult, or indeed whether the heart is that of a prize stallion , an elephant or a mouse. But for a human eye, or even a thimble for a human finger tip, it might be a different call.
How about something like a “baseball bat”. Presumably, what constitutes a “baseball bat” is defined to an inch (or a fraction of a millimeter) of its life, is it not?
You do not play baseball, now do you?
Maybe golf?
Are you familiar with the Baby-Seat case?
“I cant stop thinking back to the late 1990’s when I used to eat Snyder’s mustard flavored pretzels”
Why don’t you eat them know
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