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March 13, 2009


The best day for ICU Medical in asserting 6,682,509 against Alaris Medical Systems was the day it filed. '509 claims a needleless valve, used in medical IVs. Herein, a claim construction saga, with a written description twist, that finds the district court copasetic and ICU spiked with patent loss, shelling out for the other side's attorneys fees, and sanctions.

ICU Medical v. Alaris Medical Systems (CAFC 2008-1077) precedential

After unsuccessfully trying to puncture Alaris with a temporary restraining order (TRO) over '509, ICU amended its complaint, adding 5,685,866; 5,873,862; and 6,572,592.

The asserted claims fall into three groups: the spike claims, the spikeless (or spike-optional) claims, and the tube claims.

After a series of detailed orders and findings, the district court granted summary judgment of noninfringement of the asserted spike claims; summary judgment of invalidity of the spikeless and tube claims for failure to satisfy the written description requirement; and attorney fees and Rule 11 sanctions.

Oops. Appeal, and here they were. Another bite at the apple, with the CAFC de novo loco.

We first consider the district court's grant of summary judgment of noninfringement of the asserted spike claims, which we review de novo. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326 (Fed. Cir. 2007). Summary judgment is appropriate when, drawing all justifiable inferences in the nonmovant's favor, there exists no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). The district court's order, and ICU's challenge, is premised on the district court's construction of the term "spike." We review determinations of claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1455-56 (Fed. Cir. 1998) (en banc).

Claim Construction

The claim construction punchbowl before its spiked -

We have consistently explained that claim terms should generally be given their ordinary and customary meaning and that such meaning is one "that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). Moreover, "the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. at 1313. This last tenet derives from the fact that claims do not stand alone but rather "are part of 'a fully integrated written instrument,' consisting principally of a specification that concludes with the claims." Id. at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc)). "The close kinship between the written description and the claims is enforced by the statutory requirement that the specification describe the claimed invention in 'full, clear, concise, and exact terms.'" Id. at 1316 (quoting 35 U.S.C. § 112, ¶ 1). Thus not only is the written description helpful in construing claim terms, but it is also appropriate "to rely heavily on the written description for guidance as to the meaning of the claims." Id. at 1317. With these principles in mind, we turn to the appropriate construction of the disputed spike term.

The CAFC panel took the district court's construction as having the sharp point: "an elongated structure having a pointed tip for piercing the seal, which tip may be sharp or slightly rounded." This concurrence based upon specification support.

It is true that we should not import limitations from the specification into the claims. Phillips, 415 F.3d at 1320, 1323. But "the line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court's focus remains on understanding how a person of ordinary skill in the art would understand the claim terms." Id. at 1323. Indeed, the court should focus on how such a person would understand the claim term "after reading the entire patent." See id. at 1321. The specification never suggests that the spike can be anything other than pointed.

ICU had argued that a spike wasn't pointed, and also argued that piercing function was not in the claim. But, in claim construction, function follows form.

We have explained, however, that it is "entirely proper to consider the functions of an invention in seeking to determine the meaning of particular claim language." Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005). In Medrad, we construed the term "substantially uniform" and explained that it does not suggest "how much a magnetic field may deviate from absolute uniformity before it is no longer uniform." Id. Similarly in this case, the term spike does not suggest the degree to which the spike must be pointed. Thus adding the functional language of "for piercing the seal" is appropriate because it defines the degree to which the spike must be pointed.

ICU had argued claim differentiation, as a dependent claim (13) required "a pointed tip for piercing the seal," so incorporating the function aspect into the independent claim would render the dependent "superfluous."

Although claim differentiation counsels against construing the spike term to require the pointed/piercing features of claim 13, this doctrine is not a rigid rule but rather is one of several claim construction tools. See Nomos Corp. v. Brainlab USA, Inc., 357 F.3d 1364, 1368 (Fed. Cir. 2004); Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991) (quoting Autogiro Co. of Am. v. United States, 384 F.2d 391, 404 (Ct. Cl. 1967) ("Claim differentiation is a guide, not a rigid rule. If a claim will bear only one interpretation, similarity will have to be tolerated.")). We agree with the district court.

With "spike" defined, non-infringement of the spike claims was easily affirmed.

§112 ¶1 - Written Description

The district court found that the spikeless and tube claims lacked written description support. That's a factual finding, but the appeals court likes its de novo power.

The district court also granted summary judgment in favor of Alaris holding that the asserted spikeless and tube claims of the '509 and '592 patents are invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. Compliance with the written description requirement is a question of fact. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). Nevertheless, we review de novo the district court's grant of summary judgment of invalidity for lack of written description. Because patents are presumed valid under 35 U.S.C. § 282, Alaris must demonstrate by clear and convincing evidence that the '509 and '592 patents are invalid. E.g., WMS Gaming Inc. v. Int'l Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999).

"[T]he purpose of the written description requirement is to 'ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.'" Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004) (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)). This requirement protects the quid pro quo between inventors and the public, whereby the public receives "meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002). To satisfy the written description requirement, a patent applicant must "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). Such description need not recite the claimed invention in haec verba but must do more than merely disclose that which would render the claimed invention obvious. Univ. of Rochester, 358 F.3d at 923; Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-67 (Fed. Cir. 1997); see also PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008) (explaining that § 112, ¶ 1 "requires that the written description actually or inherently disclose the claim element").

[T]he asserted spikeless claims were not filed with the original application; rather they were added years later during prosecution.

The district court correctly granted summary judgment of invalidity with respect to the spikeless claims. As an initial matter, we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation--i.e., they do not require a spike.

The spikeless claims are more generic.

ICU's asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically--covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.

The CAFC recalled a similar case, LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005), where broader claims were invalid because LizardTech hadn't disclosed sufficiently that a person of skill in the art would understand how to do what was claimed "(rejecting also LizardTech's argument that § 112 "requires only that each individual step in a claimed process be described adequately")." "So with this patent family.

Based on this disclosure, a person of skill in the art would not understand the inventor of the '509 and '592 patents to have invented a spikeless medical valve.

It is not enough that it would have been obvious to a person of ordinary skill that a preslit trampoline seal could be used without a spike. See Eli Lilly, 119 F.3d at 1566-67 (explaining that "an applicant complies with the written description requirement by describing the invention, with all its claimed limitations, not that which makes it obvious" (internal quotation marks omitted)). ICU has failed to point to any disclosure in the patent specification that describes a spikeless valve with a preslit trampoline seal.

On the tube claims, ICU argued that a spike was a tube, but everyone else thought "that the specification distinguishes a tube from a spike."

Thus we affirm the district court's grant of summary judgment of invalidity of the asserted tube claims under the written description requirement of § 112, ¶ 1.

Weasel Tax

The district court judge was put off by ICU having made "multiple, repeated misrepresentations . . . to the Court regarding its own patents in an effort to conceal what are now characterized as errors in order to rescue the TRO/PI from denial."

According to the district court, "[i]n contrast to its objectively baseless and bad faith litigation of the TRO/PI and 'spike' claims, ICU's later unsuccessful litigation of the 'spikeless' claims involved tactics best characterized as overzealous or overly creative, as opposed to vexatious and frivolous." Id.

At least ICU offered variety in his weaseling. Attorneys fees to Alaris affirmed.

Finally, extraordinarily, Rule 11 sanctions, though no monetary sanctions were awarded.

Rather the district court acknowledged that the amount of its award of Rule 11 sanctions was "subsumed" by the amount of attorney fees awarded under § 285. Id. at 8. The district court also acknowledged that it "ha[d] sufficiently admonished ICU and its counsel for any improper conduct under Rule 11." Id. at 9.

Central District of California Judge Mariana R. Pfaelzer got it right on all counts. Affirmed.

Posted by Patent Hawk at March 13, 2009 8:02 PM | Claim Construction


"The best day for ICU Medical in asserting 6,682,509 against Alaris Medical Systems was the day it filed. '509 claims a needless valve . . ."


One of Moore's better opinions, but her dismissal of the claim differentiation argument was lame. All she said was that the claim differentiation doctrine is not a rigid rule and need not be applied. Then she didn't give any clue as to why she wasn't applying it in this case, or when it should be applied, or when it shouldn't. OK, so where does that leave us??? This is about as helpful as pigeon poop on the pump handle.

I think Moore has a malicious side that gives her a lift when writing opinions that leave practitioners moore (get it?) confused rather than less. In this regard, you can discern her hand at play in Bilski. Claim differentiation is now about as clear as "particular device."

This opinion is precedential. Hawk, it would be helpful to your legion of readers if you would indicate "[precedential]" or "[nonprecedential]" next to the CAFC opinion titles. Looks like about half of them aren't, in spite of Justice Roberts' jihad.

Posted by: Babel Boy at March 15, 2009 10:38 AM

Babel Boy,

Thanks for the insightful comment.

I agree with you about Moore. A lightweight.

My practice has been to identify nonprecedential rulings, leaving precedential rulings unlabeled. I'll take your suggestion to label them all.


Posted by: Patent Hawk at March 15, 2009 11:12 AM

Although I dislike Moore for a number of reasons, I disagree that she didn't give any hint as to why she didn't apply it here. She blatantly quoted why she didn't. "Claim differentiation is a guide, not a rigid rule. If a claim will bear only one interpretation, similarity will have to be tolerated." In other words, she says that this claim will only bear one interpretation.

I would interpret her saying this thus. If the claim is legitimately open to two different constructions, and the case has issued as a patent and thus gets the statutory presumption o validity, then doctrine of claim differentiation may be applied to sort out which construction is most proper. However, if the claim is not legitimately open to two different constructions then you don't get to use the doctrine to force a construction because the claim by itself simply means the opposite of the one you're trying to force.

Oh, and also it doesn't seem to ever be applicable in prosecution, see Ex Parte Miyazaki. Try to apply it and get tha big ol' 112 2nd.

Posted by: 6000 at March 15, 2009 6:37 PM

Haven't read the Decision yet but at first glance to your report above, Hawk, I see Moore moving away from Chef America and towards the UK Supreme Court test namely "What would the PHOSITA think the author of the claim was using the language of the claim to mean". Refreshing. Perhaps others can comment on whether this Decision is moving away from Chef America "baking bread at 400°F" claim construction. Back tomorrow.

Posted by: MaxDrei at March 16, 2009 12:25 AM

Readers, which legal test sets up the more demanding standard for allowability of a prosecution amendment, 35USC112 "written description" or EPC Art 123(2) "no subject matter can be added during prosecution"? I mean, they are effectively the same thing, aren't they? Would it make any difference, if USPTO Examiners were in the same position as EPO Examiners, being required to examine applications that are not in their own language. I mean, is it any wonder that EPO Examiners like to see verbatim support in the app as filed, for the text of any prosecution amendment. Isn't 112 headed in the same direction as Art 123(2)? If so, what's wrong with that. Apps should be drafted to a high standard, shouldn't they? Think Chef America, once again.

Posted by: MaxDrei at March 16, 2009 3:50 AM

"...if USPTO Examiners were in the same position as EPO Examiners, being required to examine applications that are not in their own language."

Not sure how many times it has to be pointed out to you, but I'll point it out one more time: a sizable portion of the USPTO are not native English speakers.

"...is it any wonder that EPO Examiners like to see verbatim support in the app as filed, for the text of any prosecution amendment."

Yes, let's elevate pedanticism to the highest level we can. That makes for very efficient examination. [/sarcasm]

Posted by: MVS = Most Valuable Stooge at March 16, 2009 7:28 AM

6000, I don't think Moore's cite to the Autogiro case was blatantly pointing out the reasons for her conclusion. She's utterly confusing. Even you, in defending her, had to rely on your speculation as to what the frick her problem was with claim differentiation.

But my problem was that after citing Autogiro and the two sentences from it about one interpretation, she then says "[w]e agree with the district court." But in the previous paragraph the district court's take on claim differentiation was based not on one interpretation. It was based on some inexplicable problem the court was having with after-added claims.

So if you actually read Moore's opinion on this point, unless you are Delphic, you come away not knowing whether to scratch your ass or scratch your head. That was my point. As I said, otherwise I think it is a very helpful opinion and I have already cited it in a reply brief to the BPAI.

Also, your point re: Miyazaki is sort of well taken. I don't disagree with it but Miyazaki is not a CAFC case, it's a BPAI case. It's one example of where the BPAI is trying to set up a double standard vis a vis the courts. So far these micro-coups haven't passed review from the CAFC, and I don't think they will. One set of laws/standards should be plenty.

Posted by: Babel Boy at March 16, 2009 8:36 AM

Will one of you put me straight, please. I had thought there was a decisive difference between:

1. Writing a set of claims prior to filing the app, in which dependent claim 13 adds to claim 1 the spike feature, then asserting originally filed claim 1 against a competitor with a spikeless tube, including invoking the Doctrine of Claim Differentiation; and

2. Filing and then, years later, upon seeing a competitor with a spikeless tube, taking "spike" out of independent claim 1, adding dependent claim 13 directed to a spike and, in litigation, invoking the Doctrine of Claim Differentiation to catch the competitor.

The difference is that 2) is covetous but 1) is not. Am I missing something?

Posted by: MaxDrei at March 16, 2009 9:54 AM

Well, Max, I don't know about covetous, but it would seem to me that both approaches are over-reaching, which is more common in the US than EPO because, as you often point out, of the different claiming standards.

And now I'm beginning to sound like Moonbeams over at PatObv.

Posted by: Babel Boy at March 17, 2009 2:19 AM

Perhaps a return to calling the corps of the BPAI "Chief Examiners" rather than "judges" would be in order to help distinguish "micro-coups haven't passed review from the CAFC".

I'll even posit that the extension of the Office wearing robes only emboldens the Office in its quest of illegal power grabs to write the law as it wants rather than apply the law as it should.

Posted by: Noise above Law at March 17, 2009 4:27 AM

I see that I have, once again, to emphasize that the EPO people, working with English as a foreign language, is not the same as Examiners, barely literate in English, working in an English-speaking PTO. To illustrate:

1. How many of the current EPO Vice-Presidents have English as their first language? Answer: none of them.

2. The current EPO President does have English as the first of her many languages. Which of her predecessors as President, since the EPO started in 1977, had English as first language? Answer: none of them.

To repeat, the EPO works with English as a foreign language and the USPTO does not. It makes a decisive difference to the appeal court's attitude to the allowability of any particular prosecution amendment. Compare, for example, the attitude in the EPO with that within the German or UK national Patent Offices.

Posted by: MaxDrei at March 17, 2009 5:32 AM