Tomorrow I’ll write about the design patent functionality questions in Ethicon Endo-Surgery v. Covidien, Appeal No. 14-1370 (Fed. Cir. 2015) (medical shears). Today, the focus is on the Federal Circuit’s reversal on indefiniteness. Here, the appellate court held that the district court had improperly invalidated the asserted surgical shear claims of Ethicon’s Patent No. 8,182,501.
Before getting into the legal details, I wanted to write about the legal posture. This case involves Ethicon’s infringement allegations against its market competitor Covidien. In a parallel case, Covidien (Tyco Healthcare) sued Ethicon for infringing its shear patents. In that case, Covidien originally won a $177 million judgment that was then vacated by the Federal Circuit who found that the district court erred in its nonobviousness decision. In a recent filing, Covidien has filed a petition for writ of certiorari on the question of whether evidence of prior invention (“102(g)(2) evidence”) is available for the obviousness analysis as the Federal Circuit held? More subtly, the question is actually phrased: “whether a mere conception that was neither known to the public nor reduced to practice at the time a patented invention was made is “prior art” to that invention under the pre-2013 version of 35 U.S.C. § 103.” [102(g) SCOTUS Petition.] This is an interesting if purely historic question since prior-invention are no longer be a legitimate claim against AIA-patents.
Back to the new indefiniteness decision: The ‘501 patented shears at issue claim an ultrasonic blade and a clamping arm that squeezes blood-vessels against the blade. The pad at the end of the clamping arm is designed with a blade-contact-area (“clamping surface area”) “so that the applied clamp force does not exceed a clamping pressure of 210 psi at the clamping surface area.” Finally, the claims also include a “means for limiting a user applied clamping force on the clamping arm creating an average predetermined clamping pressure between and including 60 psi and 210 psi on tissue disposed between the tissue pad and the blade.” In the specification, the patentee does identify a structure for limiting the pressure as a “torque wrench.” So, the indefiniteness problem here is not the ordinary Donaldson no-structure-for-MPF-element problem.
The district court found the claim invalid as indefinite because the specification did not spell-out how the pressure should be calculated. In particular, the district court identified four different ways to calculate the pressure (averaging / non-averaging / location on pad / angle considerations / etc.) that would each render a different pressure reading. And, without knowing how to calculate the “psi limits”, the claim scope lacked definiteness.
In Nautilus (2014) , the Supreme Court lowered-the-bar on indefiniteness — ending the difficult to prove insolubly ambiguous test and replacing it with a broader question of whether the claims provide a skilled artisan with “reasonable certainty” as to the scope of legal right claimed. Although the district court decided its case under the old standard, it still found the claims invalid as indefinite.
On appeal though, the Federal Circuit has reversed that finding — holding that the district court improperly ignored the intrinsic evidence and misinterpreted the expert testimony. Somewhat oddly, on the intrinsic evidence, the appellate panel found that the the pressure calculation limitation in the patent claims all require consideration of the average pressure across the pad — even though only some of the claims include the “average” limitation. Once that bit of claim construction is done (and once you decide to measure the pressure when the blade closed (~0 degree angle), then the various mechanisms of measuring/calculating average pressure all converge because of linearity involved (assuming a straight blade).
Of interest to litigators, it appears here that the Federal Circuit did give deference to the district court’s factual conclusions regarding expert testimony on indefiniteness – still finding that the district court “arrived at several clearly erroneous factual conclusions.”
On remand, the trial court will next need to interpret the scope of the ‘501 means claim terms and determine whether there is any infringement (or some other reason to invalidate) the claims.
As alluded to above, the lawsuit also involves a set of design patents covering the shears. The district court held them invalid as too functional. On appeal, the Federal Circuit also reversed that holding – finding instead that the district court evaluated the design patent claims “using too high a level of abstraction, focusing on the unclaimed utilitarian aspects . . . instead of the claimed ornamental designs.
[…] Ethicon v. Covidien: Cut to the Marrow on Indefiniteness – Tomorrow I’ll write about the design patent functionality questions in Ethicon Endo … The district court found the claim invalid as indefinite because the specification did not spell-out how the pressure should be … […]
[…] Ethicon v. Covidien: Cut to the Marrow on Indefiniteness – Tomorrow I’ll write about the design patent functionality questions … the appellate panel found that the the pressure calculation limitation in the patent claims all require consideration of the average pressure across the … […]
“If such an understanding of how to measure the claimed average pressures was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique.”
Discuss, oh ye Jepson-claim-format-is-only-an-optional-claim-format-non-believers.
Random, prior invention has been a defense to infringement since the earliest statutes. This, however, was not prior art. Not known or used was prior art.
When the defense was put into 102 in ’52, and 103 was added, its phraseology seemed to make clear that obviousness was to be measured against “prior art,” meaning, “known or used” or its equivalent. Anything else would have dramatically changed the law, and it was not congress’s intent to change the law.
MOREOVER, allowing secret prior art to be used for obviousness purposes places the US alone in the world underscoring the fact that congress was unlikely to intend to change the law in such a dramatic fashion without fully intending to do so.
And, might I add, the AIA fully intends to reverse the historic mistakes in this regard repeated made by you know who, GSR.
Ned, the US is already alone in the world in allowing unpublished prior art (i.e. prior-filed, but not-yet-published patents and applications) to be used for obviousness purposes. Everywhere else, such references are available only for purposes of either anticipation or the even more limited capacity of “prior claiming”.
While there is considerable force to your argument that 102(g) provides a defense rather than an expansion of the prior art, an international comparison is clearly no basis for determining the intent of congress!
Mark, I don’t think you actually read what I wrote.
Possibly. Our maybe you didn’t actually write what you think you wrote! Rereading what you wrote, I can see that you might have meant what I said, rather that what I thought you meant.
Glad we cleared that up!
There is a different kind of clarity that is needed.
😉
Mark, In the final analysis, you might be right that Congress could care less about whether the U. S. laws were compatible with first to file systems in any respect.
But it is true the very words statute are inconsistent with judging obviousness against so-called prior art that was not available to the inventor at the time of the invention. And this is consistent with the nature of prior art as it existed prior to 1952 – where prior art was publicly available knowledge and public use.
And this is consistent with the nature of prior art as it existed prior to 1952 – where prior art was publicly available knowledge and public use.
It was not so consistently defined, and the 1952 act itself made that clear.
You have as good of a chance of winning on the question “Does secret prior knowledge anticipate under 102a?” as you do under “Does 102g apply to 103?”
The only one who has ever said that 102a required public knowledge is the federal circuit. They do not have a good track record. The word “public” is not in 102a, and “by another” and “by the public” are not synonymous.
Random, re: 102(a), read Pennock v. Dialog. Known and used meant publicly known and used.
Prior to ’52, there was no secret prior art — except perhaps, patents as of the date of their filing.
“The defense is that Whitford was not the first inventor of the thing patented, and the answer gives notice that to prove the invalidity of the patent evidence will be offered that one Clifford invented the thing, his patent being referred to and identified.”
Milburn at 399.
Milburn was a defense to infringement case, not a case about prior art.
How does this holding on indefiniteness square with the recent Teva decision, in which the court said that Teva’s claims were indefinite because it wasn’t clear which type “average” should be used in the calculation?
Square peg,
The CAFC opinion focused on the Examiner’s insistence that “molecular weight” needed to be specified more precisely. Teva picked one of three possibilities which turned out to be incorrect based on their specification. The CAFC opinion did not disclose numbers for kilodaltons, but one may assume that the result of different measurement techniques would be significantly different.
Here, there is no suggestion that average pressure could not be measured quite readily with reasonable precision. The prior art used a pressure of 45 psi, versus a range of 60 to 210 psi in this patent. Although unstated, a measurement error of a few psi should be enough to differentiate. And, although one cannot assume the illustrated figure is to scale, the 0.033 square inch pad, if square, is 0.18 inches (4.6 mm) long. Since force is torque, which is controlled, divided by the lever arm, there would be little variation of the length of the relatively small pad, so average could be somewhere in the middle of the pad without much error.
What complicates things for me is that the reproduced figure shows a pad that contacts blood vessels at the end of a fixed lever arm. The patent did not illustrate or discuss anything different that I could see. However, in practice, both parties used a contact pad along the entire length. Thus, the actual psi is operator dependent but not included in the method claims. The figure suggests that the range of psi along the lever could vary by more than the 3.5:1 claimed, but this did not seem to be an issue for either party.
“What complicates things for me is that the reproduced figure shows a pad that contacts blood vessels at the end of a fixed lever arm. The patent did not illustrate or discuss anything different that I could see. However, in practice, both parties used a contact pad along the entire length. ”
Wow!
Now this really illustrates the central problem in this case. Does such a configuration (full length pad) even infringe given that in this context there is no way to measure the PSI at the tip?
Ned,
I think this may be the right result, but the reasoning is sloppy. Col. 3, ll. 38-41 states: “Step c) includes operating the clamping arm to exert an average coaptation pressure on the blood vessel between and including 60 psi and 210 psi.” Col. 3, ll. 49-59 discussed applying to blood vessels from about 3 to 7 mm. The pad in figure 2, is 4.6 mm in the clamping arm direction. Psi is measured when the blood vessel is squashed flat. In that case, 3 mm diameter could flatten out to almost 4.6 mm to be covered by the entire pad. 7 mm could flatten out to 10.5 mm, so the average psi would be less for the same force. However, 60 to 210 psi covers a wide enough range.
When the pad covers the entire arm, what I don’t understand is the opinion at 10: “A skilled artisan would also know that in order to find the average force applied by the clamping arm, he or she could measure the forces at the midpoint of the clamping surface area—which for Ethicon’s surgical shears is the midpoint shared by both the tissue pad and clamping arm.” This is because, at 8: “And in the case of a simple lever, … measured force has a generally linear mathematical relationship with distance … and the midpoint of the lever arm is representative of the average force.” It just ain’t so. With a fixed torque (Ethicon uses a torque limiter), force is inversely proportional to the distance from the pivot, and T = r x F.
Nonetheless, at 10: Ethicon’s expert also conducted tests … which demonstrated, inter alia, the general linearity of clamping force along the clamping arm, and how force measurements at the midpoint of the clamping arm approximated the average of two force measurements taken at proximal and distal locations 1/3 and 2/3 of the way along the clamping arm.” Yes, the average of 1/(1/3) and 1/(2/3) = 2.25 = approximately 1/(1/2) = 2. Try it at 1/10 and 9/10 of the way.
However, a skilled artisan would understand to measure the psi exerted on the blood vessel. One would have to take into account the size of the blood vessel and the width of the pad. Ideally, this should be at the end of the arm to avoid protruding into surrounding tissue.
the question is actually phrased: “whether a mere conception that was neither known to the public nor reduced to practice at the time a patented invention was made is “prior art” to that invention under the pre-2013 version of 35 U.S.C. § 103.”
What a silly question. That is a statement of 102g, and 103 expressly incorporates the 102 anticipations. It represents both a fundamental misunderstanding of 103 and a lack of historical reading that for the majority of patent law’s history “secret” prior art was perfectly fine for anticipating.
In doing so, the district court was troubled that Ethicon used four different methods to measure clamping force, and that each of these methods appeared to yield different force measurements…Ethicon’s witness explained that “[i]f you took [results from] all [four of] the methods again and again and again, the average of all those [measurements] should be quite similar to each other.”
This case is rather dull because there’s no real conflict, assuming there was proper claim construction done.
*IF* the district court was correct that one would receive different results from different methods then you would clearly have an indefiniteness problem. This is shown by the treatment of the Honeywell case:
Third, the different sample preparation techniques produced measurements of the claimed feature that “var[ied] greatly.”
Since that does not appear to be the situation in this case, there clearly isn’t an indefiniteness problem.
But one interesting point is to note the shell game that occurs between this case and say, Nautilus. Here the Fed Cir finds no indefiniteness when
the definiteness requirement of 35 U.S.C. § 112 mandates only that one skilled in the art must be able to understand which pressures are relevant to the claims and how those pressures can be measured, so to discern the scope of the claimed average pressure range with reasonable certainty. See Nautilus, 120 S. Ct. at 2124. If such an understanding of how to measure the [claimed value] was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique.
Nautilus necessarily lacked that “understanding of how to measure” (as that was the undescribed novel functionality that made it patentable) and there it was called an enablement issue rather than an indefiniteness one. This statement is problematic for the Fed Cir because if two measurements would result in substantially different result (not the case here, was the case in Nautilus) you would still have indefiniteness despite a measurement technique being within the skill of the art. Nautilus was just a wrongly decided case.
The Fed Cir keeps cutting corners on indefiniteness. It probably didn’t lead to a wrong result here, but it’s only a matter of time until it does. Reasonableness is a two-tailed test, and they are constantly making one-tailed test statements. Here the nomination of a particular measurement method would not have provided further clarity, and therefore the information can assuredly be left out and maintain reasonable certainty. That is not often the case.
You can’t just leave out words that matter and expect the same boundary. That’s why they’re called “limitations” after all.
the appellate panel found that the the pressure calculation limitation in the patent claims all require consideration of the average pressure across the pad — even though only some of the claims include the “average” limitation.
Whoopsie. You had the right conclusion and then you went and stripped the claim word “average” of meaning in your claim construction.
Chen makes it clear that PSI was “average” according to the spec. The judge was fooled because the defendant used different methods itself. Apparently, the judge never read or did not understand the spec. I suspect the latter.
If we wanted to improve patent litigation, congress should hire these several hundred senior patent attorneys, now PTAB APJs, as special masters advising inexperienced judges like this one in Ohio.
Chen makes it clear that PSI was “average” according to the spec. The judge was fooled because the defendant used different methods itself. Apparently, the judge never read or did not understand the spec. I suspect the latter.
Entirely possible, which is why the Fed Cir is likely right.
However, you do have to question what you do from a claim construction standpoint when it only includes a limitation some of the time. The word average has to have a meaning, it has to do something. If the method was limited to the average without saying it, then why say it in some claims? Doesn’t the inclusion in some claims mean that other claims are not limited by the average?
In Lizardtech, the specification was clear that it used seamless DWT. Seamless DWT wasn’t in every claim. Was the act there to limit the non-limited method to the specification meaning, or was it to find the non-limited claims overbroad? Sure Lizardtech was a lack of description case, but certainly (at least under an actual test) it would not be “reasonably certain” to leave the limitation out.
The distinction, I think, is that Lizardtech sought to use the lack of the limitation against the infringer and it would have made a qualitative difference in the outcome, not so here, but that isn’t a cannon of construction now, is it? How does equity play into this, and Nautilus?
If the spec was clear, the claims did not even have to mention the measurement technique. Including it in some claims was mere redundancy.
Including it in some claims was mere redundancy.
Well that’s the opposite of construction cannon, isn’t it?
Besides, your argument would have validity if it included “average” in all claims or in none of them – then you can talk about how much of the specification method is conjured absent the word. When you put average in only some of the claims the intent is to limit some claims and not others, because you have to give effect to all words.
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