Stent Patent Cannot Heal Divided Claim Construction: Four Judges = Four Different Claim Constructions

By Dennis Crouch

Bruce Saffran v. Johnson & Johnson (Fed. Cir. 2013)

Claim construction has become the most highly contentious issue in patent litigation.  A difficulty with claim construction is that the question does not involve a yes/no answer.  Rather there are a wide variety of possible constructions for any claim element.  Thus, the likelihood of a court randomly picking the correct construction is quite low. And, as it turns out under the rules of de novo review, even when the lower court applies reason and evidence to the problem it it often arrives at the wrong answer. That wrong answer leads to a reversal of the claim construction on appeal.  To be clear, claim construction falls in line with the normal plaintiff/defendant divide. Plaintiffs (patentees) tend to prefer no construction and just let the jury figure out whether the claims are infringed.  Defendants (accused infringers) see claim construction as a mechanism for removing the case from the jury based on the technicality.  Thus, most serious claim construction arguments are designed around the prospect that a favorable decision will lead to summary judgment for the defendant.  Although we often hear of "overly broad" patent claims, the reality is that some defendants ask for a narrow construction in order to build their non-infringement argument while other defendants ask for a broad construction in order to build their invalidity argument.  Of course, the high burden associated with proving invalidity tends to make the first approach a better strategy. In addition to the myriad potential constructions for each term, a typical patent claim has dozens of potentially disputed claims – making the combinatory possibilities quite large.

Background: This case involves Dr. Bruce Saffran's U.S. Patent No. 5,653,760 that claims the treatment of damaged living tissue by covering the tissue with a selectively permeable barrier that could be wholly introduced or applied as a spray. As designed, the device could then allow for the release of a treatment drug that would be able to pass through the membrane while larger molecules would be blocked. The specification explains that the selectively permeable membrane would be useful in the stent market in order to protect blood vessel cells as they regenerate. Saffran previously settled with Boston Scientific for $50 million. In this case he won a $500 million verdict (plus interest) against J&J for its infringing stents.

In a divided opinion, the Federal Circuit has flipped the verdict — finding that the lower court had erred in claim construction and that under the proper construction J&J's stents do not infringe.

The decision is interesting because it includes three opinions that all agree in the judgment reversal, but each disagrees as to the correct construction. In all, four judges have considered the claim construction and have come out with four different claim constructions. The basic dispute is over two claim terms:

  • "Device": Whether that term should be interpreted to require a sheet.
  • "Means for release of … treating material": Whether the means can generally include chemical bonds and linkages or only hydrolyzable bonds.

The four judges outcome on these two questions is shown in the two-by-two table below.

   

Claimed means limited to hydrolyzable bonds

Claimed means includes chemical bonds and linkages

"Device" requires sheet

Judge Lourie –

No Infringement

Judge Moore –

No Infringement

"Device" does not require sheet

Judge O'Malley –

No Infringement

Judge Ward -

Infringement

Whither Cybor: The Federal Circuit is currently reconsidering whether Cybor was correctly decided – i.e., whether deference should be given to the lower court claim construction ruling. If deference had been given, it may well be that Judge Ward's opinion would have carried the day – with the resulting conclusion that the $500m verdict should be upheld. As others have written, that result does not actually solve real problems — only masks them.

23 thoughts on “Stent Patent Cannot Heal Divided Claim Construction: Four Judges = Four Different Claim Constructions

  1. That’s horrible, MD! A childhood without the Cat in the Hat, Fox in Socks, Sam-I-Am, Horton, Yertle the Turtle, and Bartholemew Cubbins (with his 500 hats)? The Owl and the Pussycat is a really poor substitute, and Roald Dahl is more than a bit creepy, if you ask me.

    Incidentally, it was the moss-covered three-handled family gredunza that first sparked my interest in technology. I still haven’t figured out exactly how that thing works.

  2. Got me there IANAE. I know Sir Humphrey but had no idea who is the Cat in the Hat. I do now though. On this blog one learns all sorts of useful stuff. Thanks.

  3. The more I see this disclaimer practice, the more I do not like it. One has a piece of prior art and says that it does not have X feature, which is claimed, but then one goes on to say that the prior art also does not have Y feature. But Y, as a point of fact, is not in the claims, but is a feature an embodiment described in the specification.

    I think that is what happened here. “Sheet” is not a claim element. Nothing in the claim says anything about sheets.

    From my experience, when one argues features not in the claims, the examiner typically responds with a laugh and a shrug and effectively says, so what? They will then suggest you add that feature to the claims if you want to rely on it to distinguish the prior art.

    So, what do we have when the applicant says both X, a claim element, and Y, a feature not claimed? I would suggest that the examiner relied on X and did not rely on Y, and every patent attorney worth his salt would know this.

  4. The patent office doesn’t ever make “a construction” in this proceeding, it simply verifies whether or not the patent can be issued under the construction proposed by the patentee under 35 U.S.C 151. And so long as this proposed construction from the patentee is not unreasonable from the get go (and thus would not be sent to the PTO in the first place because the claim was not amenable to two or more constructions) then the patent goes back to the court with the construction thus decided already (because the office specifically issued the patent under that construction), and the judge no longer gets any additional say in the matter.

    If the PTO finds an issue with the patentees proposed construction under art, or 101 or new matter etc (disregarding a miyazaki 112 which is the whole reason the patent is back at the pto in the first place from the district court) then the patent does not reissue and then we can either have further examination or the patent is abandoned or whatever you guys want to add on at this stage. The court case is effectively over/suspended for now of course if this happens.

    Just as an aside, perhaps you could control for situations where the claim is horrendously drafted in order to mean what the patentee is proposing, and do so under 35 U.S.C 112 2nd if you really want. This of course would be because the patentee failed to claim what he subjectively believes to be his invention as noted in his claim construction.

  5. device: A contrivance or an invention serving a particular purpose

    That’s it. Absent an express definition in the spec that is different, the term “device” has no other limitations, ever.

    Ward handled this correctly, I think, saying the “device” was the elements claimed in the body.

    Of course that’s correct.

    coated wires were an example and she said this example was not a layer.

    On what planet is a “coating” not also a “layer”?

  6. I propose the following solution:

    Where a claim term upon which a case will hang is amenable to two or more constructions the case shall be forthwith transferred to the jurisdiction of the patent office for further proceedings and possible reissue, if the claim would still be issued under 35 U.S.C 151, under the construction preferred by the patentee. The patent office shall be given a time of a week to accomplish this task.

  7. MM, indeed, the claim required layers, but the “device,” not the layers were said to have the functional capability.

    “the device being capable of substantially restricting the through passage of at least one type
    of macromolecule therethrough.”

    Ward handled this correctly, I think, saying the “device” were the elements claimed in the body. That focused the porosity limitation on the layer.

    As one judge noted, coated wires were an example and she said this example was not a layer.

    But, then, we have the statement in prosecution that said the device was a sheet.

  8. Just a couple of points:

    The disclaimer was inconsistent with the broad disclosure and numbers of examples not sheets, like coated wires. The accused device, I think, had coated wires.

    Thus the debate on this issue was, in part, disclaimer vs. disclosure.

    In another part, the disclaimer was part of a sentence that distinguished the prior art on two grounds, where the examiner did not indicate which one he relied on.

    Given this combination, the disclaimer was “unclear.” However, the majority was harsh on this point, essentially holding the patentee to the specific stent embodiment disclosed.

    On the means, hydrolyzable bonds was given as an example of generic bonds. I don’t understand at all why the court limited the claims to the example.

  9. He nearly always fails to take into consideration what the specification actually brings to the claim terms, and construes claim term in a near vacuum. In my opinion, that is an incorrect manner to construe claim terms.

    Not just your opinion. It’s the opposite of what is required under Phillips.

  10. where the singer asks us “do I really feel the way I feel”, tell us anon (because I’m sure you know you know), does he really really feel the way he feels? Or is it that he only “thinks” he really really feels the way he feels the way he feels? Or is it that he doesn’t actually feel the way he feels?

    Thanks, Max. Now I know what it would have been like if Sir Humphrey Appleby and the Cat in the Hat had a baby.

    I suspect they won’t be the only ones having kittens.

  11. A better second thought would have been one to occur to you before you hit the ‘post’ button.

    Your post at 9:36 rather misses the point that it is only that you think you know something about C&C that drives your ad nauseum crusade against it.

    Your crusade against C&C is rather hollow and tiresome, but we both know you know that, right?

  12. In that song about Memphis, where the singer asks us “do I really feel the way I feel”, tell us anon (because I’m sure you know you know), does he really really feel the way he feels? Or is it that he only “thinks” he really really feels the way he feels the way he feels? Or is it that he doesn’t actually feel the way he feels?

    On second thoughts, don’t bother.

  13. I don’t assume, anon, I think I know.

    Corrected.

    (and you are wrong – but that has never stopped you in the past, and likely never will, as we are now on what, the 81st cycle of your repeated 6-months of experience…?)

  14. I don’t assume, anon, I know. I don’t ignore the basis for C+C. I know that too.

    I don’t “need” to prove anything to you, anon. It is other readers I’m addressing myself to. Readers with enough experience to form their own opinion whether or not I’m right.

    I note with satisfaction that there is one thing on which we agree, namely that there are things other than C + C which harm the reputation of the patents courts of the USA.

    Incidentally, how many judges do you know, that suffer under “an inability” even to talk or to participate in reaching a consensus? I put it to you that there are in fact no such judges at all. It is not as if the judges here can’t agree, is it? I put it to you that they are deliberately using this simple set of facts as a test case, running three flags up the pole to provoke a debate and perhaps set up a referral to SCOTUS on a case that is not too hard for the venerable and learned non-specialists at the Supreme Court.

    If you persist in your assertion that there are some judges who lack the ability to talk, perhaps you could furnish proof of what you assert.

  15. Perhaps, a low standard for I have seen many of Judge Ward’s claim constructions. He nearly always fails to take into consideration what the specification actually brings to the claim terms, and construes claim term in a near vacuum. In my opinion, that is an incorrect manner to construe claim terms.

  16. You assume that “getting to the correct one” is impeded by C&C.

    Sorry, MaxDrei, you assume a conclusion you would need to prove. You ignore the basis for the C&C in the first place. You think “reasonableness” exists somehow in a vacuum outside of the purpose of having an examination system in the first place. (I would grant you that a preponderance standard may have a place in a pure registration system – but that’s a different kettle of fish).

    The ‘reputation’ is not harmed by the C&C – it is harmed by bad or lazy judging, by an inability of the judges to talk to each other and come to a consensus view.

    Again, other than your (quite silly) mantra against C&C,… um, why?

  17. Why? So that judges who have sat through the case, right through till after trial, and have by then formed a considered, educated, wise opinion on both infringement and validity can get to the correct one of the four fields of the 2 x 2 matrix. With C +C there are impeded from getting to two out the four fields. That impediment distorts the jurisprudence, as they squirm to do justice when prevented from ruling that, actually, the asserted claim is, on any reasonable view, invalid.

    I don’t like the squirming. I think it does serious long term damage to the reputation of the patent courts. I’m not out to get the courts. On the contrary, I would like to see their reputation growing ever higher. But under the law given them to interpret, I think that’s impossible.

  18. Thus, the likelihood of a court randomly picking the correct construction is quite low.

    Did you really mean to say this?

    I certainly hope courts are not randomly picking constructions and hoping they hit the right one.

  19. set at a preponderance showing

    Other than your long-standing mantra against the C&C standard,… um, why?

  20. Delicious case. But, Dennis, were the jury-decided damages really only USD 500?

    The difficulties have their roots in 112-6 and file wrapper estoppal. Both peculiar to the USA.

    I like the 2 x 2 matrix. If only the USA used a simple 2 x 2 matrix when deciding the core issues of validity and infringement, with the horizontal and vertical lines set at a preponderance showing. Then there would be no need for 112-6 and FWE and then claim construction would fall out easier. Every tweak to the law in turn generates more tweaks. Kiss kiss.

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