The Essential Element Test and ICU Medical

In discussing the recent ICU Medical case, I noted that Judge Moore’s decision did not rely on the “essential element” test or even cite Gentry Gallery. In Gentry Gallery, the patent covered a sectional recliner. During prosecution, the patentee had amended its claims to drop any reference to the location of the recliner controls. The Federal Circuit held those later-drafted claims invalid because the location of the controls was an “essential element” of the invention that must be included in the claims – otherwise, the claim scope would be unduly broad. Following Gentry Gallery, however, the Federal Circuit stepped-back from the essential element language– instead narrowing the case holding to the well trod notion that claims should be limited to the supporting disclosure. In both Johnson Worldwide, and Cooper Cameron, for instance, the Federal Circuit explicitly denied that Gentry Gallery created any new requirement.

“[W]e did not announce a new ‘essential element’ test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements.” Cooper Cameron, 291 F.3d 1317 (Fed. Cir. 2002)

In parallel fashion to Gentry Gallery, ICU had included a “spike” in every embodiment and each original claim. During prosecution, and apparently after seeing competing products, ICU amended its claims to drop the “spike” limitation. This was important because the market had moved to a spikeless version of IV valves. This district court in ICU discussed Gentry Gallery and the essential element test, but found no need to base its ruling on that “disfavored” theory. Rather, the court based its analysis on the traditional notion that claims must be described in the specification.

“[T]he Court’s analysis employs the accepted rule that the claims may be no broader than the supporting disclosure, or, conversely, that claims are invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. By focusing on the language of the Common Specification in a manner that highlights the function of the “spike” element, and the frequency and ubiquity with which it is referenced, the Court is only attempting to discern the breadth and substance of the invention ICU actually disclosed in the original 1992 Application.”

Although the district court denied its application of any “essential element” test, it went on to hold that any valid claims must include a spike:

“The pervasiveness of the “spike” element in the invention description clearly informs the Court, and would inform any reasonable juror, that what was disclosed and claimed as the invention in the 1992 Application was a needleless medical valve with at a minimum, a “body,” a “seal” and a “spike.””

Likewise, the Federal Circuit’s version denies an omitted element test, but held that any valid claim must include a spike limitation because “a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”


  • ICU Medical Part I
  • ICU Medical Part II
  • ICU Medical Part III
  • The essential element and omitted element test are largely interchangeable, although some logical distinction could perhaps be made.

49 thoughts on “The Essential Element Test and ICU Medical

  1. 49

    It is interesting to see several CAFC decisions invalidating medical device claims for this odd mixture of absence of written description, broader than the invention and late claiming as these 112 defenses/rejections, now characterized as lacking or construing the claims to require an “essential element”, used to be called.

    Does anyone know the status of litigation brought by Dr. Wall in the last few years against the stent manufacturers in ED Texas? This decision should put another nail in the coffin of his Patent No. 6,974,475 that issued in 2005, 18 years after filing (therefore getting the 17 years from issue term) with sets of claims directed at a “plastic coating” on metal or fabric stents. All embodiments are directed to a stent having a gap through the tubular side wall extending from end to end and interlocking mechanisms to enable the stent to be introduced collapsed on a balloon catheter and expanded by inflating balloon to lodge it in situ (as was conventional), such that the mechanisms engage to keep it expanded. In the description, the “plastic coating” shown as 32 with openings 34 might be polyethylene, polyester or PTFE, but there is no mention or suggestion of the drug eluting coatings on the stents charged with infringement.

    The initial focus of prosecution back in the late 80s was directed to the interlocking feature alone or combined with the plastic coating, and such claims were rejected over an earlier filed Kreamer patent no. 4,740,207 or in combination with Palmaz patent no. 4,739,762 describing a plastic coated metal stent. An interference against Kreamer was declared that Kreamer won. So, the Wall claims to the interlocking feature were narrowed to recite either the plastic coating or specific interlocking mechanisms not shown in Kreamer. These Wall patent claims are not practiced by anyone at present.

    The public PAIR records show an unexplained almost 9 year hiatus in prosecution following the interference loss. But, a companion application was filed in 2002 that introduced the sets of claims reciting only the coating 32 with openings 34. Perhaps the drug coated stents introduced by J&J, Abbott, BSI, etc., prompted refocusing prosecution on these newly introduced plastic coating claims. Prosecution in that copending application resulted in allowance of the claims, and they were transferred into the `475 application to be allowed there. An extensive 131 declaration was filed in the copending application with supporting declarations to remove Kreamer and Palmaz. But, I could not see any disclosure in those declarations of the specific coating with openings of the allowed claims and shown in the application drawings that would antedate Palmaz. To me, any coating on the metal struts of Palmaz would inherently result in the coating and opening limitations, and it is not clear that the inventor had conceived of that coating prior to the Palmaz filing date.

    So, it seems to me that the asserted claims are vulnerable to a number of defenses including the lack of an enablement and written description of any suitable plastic coating that would embrace drug coatings. The interlocking mechanisms may also be an “essential element” missing in these claims.

  2. 48

    “I’m baffled”

    Don’t worry Max, its not you. Its like trying to make sense of the crazy guy at the subway. He sounds like he’s making sense, you want to try to make sense, but alas, it is meaningless gibberish.

    Welcome to the Mooney experience.

  3. 47

    What if the specification had only disclosed and initially claimed “green” valves, but failed to include a statement that some embodiments are not green? The point is that specifications will now need to include such a statement for every single initially filed claim element, regardless of how small and insignificant?

    Furthermore, in view of Sitrick and ATI v. BMW, this statement will do nothing to help the heightened requirement of fully enable EVERY embodiment that is now implicated by such a broadening statement used to handle WD, right?

  4. 46

    I fail to see why anyone is getting worked up about ICU. In the specification and claims (considered part of the specification) as originally filed, the application only describes and claims valves with spikes. By doing this, the Applicants have set the bounds of their invention as being valves with spikes.

    At some later date, a competitor comes up with a way to make an operable valve without a spike. Since such a valve is outside the bounds of the application in question, the competitor comercializes the spikeless valve.

    The Applicants, presumably after becoming aware of their competitors product, decide to add new claims to their application that would cover both spiked valves and spikeless valves. The scope of the claims are now beyond the bounds set forth in the originally filed application. The claims therefore now encompass matter not described in the original application (spikeless valves). Some might even call this matter “new”.

    Maybe I’m crazy, but it seems to me that the prevention of the broadening of the scope of an application to cover a competitor’s product is EXACTLY what the written description requirement was created for. The fact that, in this case, the scope of the application was broadened by removing a limitation is irrelivant.

    If the specification contained the sentence “In some embodiments, the valve does not contain a spike,” the new claims would have met the written description requirement, and likely would have been enabled given the knowledge of one skilled in the art.

  5. 45

    Also, ICU is indeed a very remarkable case because it extends Gentry without relying upon any of the “problems” from which the Gentry specification was found to suffer.

  6. 44

    Once upon a time there was a line between predictable arts and unpredictable arts that protected the predictable arts from the immensely vague 112(1) enablement and written description jurisprudence. Unfortunately, the courts have now erased that line.

    Won’t patent specification drafting now become a dance of one step forward, two steps back, for every disclosed element? For example, “The disclosed widget has element A, but the scope of the disclosure includes embodiments with elements A’, A”, etc., as well as embodiments WITHOUT A or any functional equivalent of A, since such embodiments could be enabled as follows…”

    Is the court really going to make us do this dance, at the risk of losing our licenses, for every single feature of an invention in the predictable arts?

  7. 43

    Poppa, thanks. In haste:

    Sitrick: Mooney addressed this point, that the comparison is between the claim and the single, real life accused embodiment in particular.

    Monsanto: I see the judge using “any” and “all” but not “embodiment”.

    Goodman: ditto

    So, I’m still not yet totally convinced. I cling to my interpretation, that the judges are thinking about “all” the embraced scope, and concrete specific embodiments in the case, rather than all the notional imaginable embodiments that a claim wording embraces.

    Perhaps we are both stretching, to get to the meaning we prefer. Perhaps other contributers will put us straight?

  8. 42

    Max, here are the judge’s own words:

    Sitrick v. Dreamworks, 516 F.3d. 993 (Fed. Cir. 2008) (Judge Moore): “Because the asserted claims are broad enough to cover both [embodiments], the patents must enable both embodiments”.

    Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352 (Fed. Cir. 2007) (Judge Rader): “The district court correctly construed [the asserted claim] to require the claimed [limitation] to function in any [embodiment]”; “In Vaeck, this court held the limitation… required the claimed [limitation] to function in all [embodiments].”

    In re Robert Goodman, 11 F.3d 1046 (Fed. Cir. 1993) (Judge Rader): the “specification does not enable one skilled in [in the art at the relevant time] to practice the method for all [embodiments] as application claims […] require.”

    Assuming that we agree that “all” is synonymous with “every”, in what way have I misquoted or quoted out of context?

  9. 41

    Afterthoughts to my post above: Gentry is different from this case. In Gentry, the reader doesn’t need to be taught how to put the console elsewhere but, in ICU, the app doesn’t enable spikeless embodiments because it doesn’t give the reader any clue whatsoever, how you can get the device to work, if you don’t resort to a spike.

    Bartmans, I mis-spoke, it was Mobil, not Exxon. Have you any thoughts on its anti-wax case, at the EPO? As I understand it “essential element” is in Gentry and NOT relied upon in ICU. But never mind that. Perhaps you could now comment on the “all essential features” test at the EPO, under Art 84 EPC?

  10. 40


    there is a contradiction in your analysis: if that one out of a 1000 embodiments is inoperable, how can then an infringer make or sell it?
    By the way, in Europe more or less the same situation holds and may be even more extreme: a claim is found enabled if there is at least one embodiment described in an enabling manner in the application as filed.
    On the other hand (reverting back to the original subject of this topic) there is no such thing as an essential element test under the EPC. However, the courts now and then use this for determining invalidity of a claim. Several cases in The Netehrlands (als fairly recent) have been decided on that issue.

  11. 39

    Attention Paul Cole. Are you there. Poppa and friends need your counsel. In your absence, I’ll try (but I’m not as good at this as you).

    A case in Europe is the Exxon case where substance A was useful as an additive for diesel fuel, to stop wax formation at Alaska-cold temperatures. Now I know it’s chemistry, but the same principle should apply in ME/EE, because even ME/EE isn’t totally “predictable”. The fundamental, since the dawn of time(common sense actually) principle which underlies all of human contractual relationships, including patent law, is that you ought to get in proportion to what you give.

    Exxon claimed functionally, an additive (any additive, that is) with that effect, but had as Examples just one single solitary substance that “worked”. The EPO thought that Exxon hadn’t enabled over the full width of the claim, so rejected that claim. They used Art 84 EPC but could equally well have used Art 83. Malcolm there must be tons of biotech cases that raise the same issue, but I suppose the PTO uses some other statutory provision to reject them. Call it what you will though, the underlying principle is what stays constant.

    I think it would have been different if Exxon had suggested a possible mechanism, and other substances able to deliver that effect (but maybe they had in mind follow up applications for that). With such a suggestion in their app, they would have been able to assert that they were enabling “over the width of the claim”.

    Likewise, any suggestion at all, in the original app, that you don’t need a spike to solve the problem, or don’t have to have the sofa console plumb centre, would have been enough, no?

    Poppa, aren’t you putting words in the judges’ mouths here. Which one of them actually said “every embodiment”?

  12. 38

    Assuming arguendo that somehow the quotes don’t support what they say, what did the Federal Circuit mean in Sitrick v. Dreamworks, 516 F.3d. 993 (Fed. Cir. 2008) and Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274 (Fed. Cir. 2007)?

  13. 37

    fishbone, I ain’t playing 20 questions. I gave the straightforward answer to Poppa Bear’s strangely worded query, i.e., “Would that “full scope” not include “every” embodiment?”

    Poppa Bear was referring to this quote: “The full scope of the claimed invention must be enabled.” Sitrick v. Dreamworks, 516 F.3d. 993 (Fed. Cir. 2008)

    That case cite in its “naked” form is problematic for the reason I highlighted. Now you ask whether every “operative” embodiment falling literally within the scope of a claim needs to be enabled as of the application filing date? Honestly, I don’t think so. If there are 999 “operative” embodiments enabled by the spec but one “operative” embodiment that was not enabled at the time of filing, I think the claim is likely valid. HUGE CAVEAT: if that single non-enabled (but subsequently “operative”)embodiment happens to be the embodiment that the alleged infringer is making or selling, you are asking for trouble. See, e.g., Leibel-Flarsheim.

  14. 36

    “The “full scope” does not include “every” OPERATIVE embodiment, as a matter of well-settled law.”

    Do you agree, Malcolm?

  15. 35

    The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).

  16. 34

    I’m baffled. There’s always an infinity of embodiments within any claim envelope. Here in Europe it’s a sine qua non that the claim must enable at the same level of generality as the claim ie over the full scope. But nobody supposes that this means “enable every embodiment”. I don’t even understand where the difficulty lies (or why a citation should be needed).

  17. 32

    Please explain your statement, Malcolm that “The “full scope” does not include “every” embodiment, as a matter of well-settled law.” Thanks

  18. 31

    “Would that “full scope” not include “every” embodiment?”

    The “full scope” does not include “every” embodiment, as a matter of well-settled law.

  19. 30

    “The full scope of the claimed invention must be enabled.” Sitrick v. Dreamworks, 516 F.3d. 993 (Fed. Cir. 2008)

    Would that “full scope” not include “every” embodiment?

  20. 29

    Mischaracterizing, as it is not my stated position, but rather Judge Moore’s in a particular case. Instead, I posed a question regarding the potential vitality of that case. And I like your trade secret retort.

    Nevertheless, I apologize if I stoked a flame.

  21. 28

    Myself, I’m sceptical Poppa whether the quotes substantiate your proposition that “every” embodiment within the scope must be enabled. Infringer could make such an embodiment using trade secrets, for example, (secret wonder spicy coating, perhaps)then contend that the patent doesn’t enable that embodiment. But that shouldn’t invalidate the claim, should it? More Chicken Little behaviour Poppa? Or am I mischaracterizing your position?

  22. 27

    Yes, to properly obtain a genus claim, one must enable and possess its subject matter.

    If, during prosecution, one narrows a genus claim to a species claim, to properly obtain that species claim, one must enable and possess its subject matter.

    It seems the Federal Circuit and its predecessors have had a firm grasp on these concepts for quite some time.

    Perhaps the more interesting question is whether other panels of the Federal Circuit will follow Judge Moore’s recent Sitrick decision, which demands that the application must enable every embodiment that falls within the scope of each of its asserted claims.

    “Because the asserted claims are broad enough to cover both movies and video games, the patents must enable both embodiments”. Sitrick v. Dreamworks, 516 F.3d. 993 (Fed. Cir. 2008) (citing Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1285 (Fed. Cir. 2007) (“Disclosure of only mechanical side impact sensors does not permit one skilled in the art to make and use the invention as broadly as it was claimed, which includes electronic side impact sensors.”).

  23. 26

    Oh dear. I made a mistake, to utter the dirty word “monopoly”. My point was simply that if you want an exclusive right that is wide-ranging (say: A growth regulator for “plants”) then you should be required by the law to make plausible in your app as filed more than regulation of the growth of just one single plant variety (say: mustard seedlings) out of the countless species of “plants”. And if your “plants” claim is untenable, and you narrow down to, say, brassicas, then your appln as filed should reveal some basis for your sheep/goats proposition that brassica growth control is the invention, while all other plant species are not part of your invention. Seems to me that the CAFC is belatedly onto this “undisclosed intermediate limitation” game, and is going to stamp it out. Are we not embarking now on an era of more attention being given to dependent claims, in apps as filed, as realistic future fall-back positions (as opposed to mere claim differentiation tools, artificially to inflate disingenuously the apparent scope of claim 1, if and when needed, years later)

  24. 25

    US law does not allow patent rights to be awarded in proportion to anything. It is an all or nothing proposition. Either the claimed subject matter is possessed and sufficiently enabled or it is not. If a given examiner justifies an award of a particular claim based on some proportionality concept, that examiner is acting outside the law.

    Moreover, at least according to the USPTO (i.e., Ex parte Lundgren), there is no “technical field” requirement.

    As for the notion that the exclusive rights provided by a US patent are somehow equivalent to monopoly rights, Judge Rich probably explains it best:
    “Ask the average man whether ‘monopoly’ is bad and he will undoubtedly tell you it is. ‘Ask him why, and he will say that monopolies gouge the public. To talk of ‘patent monopoly’ weds patents to prejudice, which is not conducive to clear thinking.”

    That is, from an economic perspective (Judge Rich was trained as an economist), the granting of a patent is not a grant of market power, and thus is not a grant of monopoly rights over any inventions defined by the claims of that patent. This is not to say that a patent owner can not gain market power, nor that a patent can not help them do so, but merely that the issuance of a patent does not convey market power, and thus not monopoly rights.

    “A patent does not of itself confer market power or a presumption thereof for purposes of the antitrust laws.” See Medimmune, Inc. v. Genentech, Inc., 427 F.3d 958 (Fed. Cir. 2005) (reversed on other grounds); C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1368 (Fed. Cir. 1998) (“It is not presumed that the patent-based right to exclude necessarily establishes market power in antitrust terms.”); Abbott Labs., 952 F.2d at 1354 (Fed. Cir. 1991) (“A patent does not of itself establish a presumption of market power in the antitrust sense.”); American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1367 (Fed. Cir. 1984) (“patent rights are not legal monopolies in the antitrust sense of the word”); Jefferson Parish Hosp. Dist. No. 2 v. Hyde, 466 U.S. 2, 18 (1984) (“any inquiry into the validity of a tying arrangement must focus on the market or markets in which the two products are sold, for that is where the anticompetitive forcing has its impact”); In re Independent Service Organizations Antitrust Litigation, 203 F.3d 1322, 1329 (Fed. Cir. 2000) (“patent alone does not demonstrate market power”); Independent Ink, Inc. v. Illinois Tool Works, Inc. 396 F.3d 1342, 1348 (Fed. Cir. 2003) (“the Supreme Court has held that there is a presumption of market power in patent tying cases”), cert. granted, 125 S. Ct. 2937 (June 20, 2005); Herbert Hovenkamp, Federal Antitrust Policy: The Law of Competition and its Practice §10.3 (3d ed. 2005) (“most patents confer absolutely no market power on their owners”).

  25. 24

    Max: I suspect that we agree that just as there can be many applications that claim priority to a given application, can be many claims in each of those applications.

    Under US law, each claim can define an “invention”. For any given claim to be valid under US law, the specification must enable and provide written description for the “invention” it defines. Is the law in Europe so different?

  26. 23

    Just so, Gratzi. Now, as to the thing called the specification. It is a written description of “something” right? Not the weather for today, or what I had for dinner last night but actually (unless I’m very much mistaken: and maybe I am) something we can call “the invention”. I’m keen to be contradicted though, by those who are of the US patent law world rather than that of the rest of the world. Maybe(at least up until Liebel-Flarsheim and this case) the specification is deemed to have completed its statutory task in the USA, the moment it enables just one single pinpoint embodiment, also the “best mode”, within the vast envelope defined by claim 1. But that would be crazy, no, because it doesn’t serve the public interest, that monopoly rights are an exception to free competition, and only to be awarded in proportion to the contribution that the inventor has made to the technical field?

  27. 22

    Max: I’m not sure I follow most of your comment, but in the US, “the invention” is defined by the claims, unless the description limits it otherwise, as was done in this case.

  28. 21

    But Gratzi, would it also be shenanigans if a top drafter carefully writes “embodiment” at the front of every sentence, leaving as the “invention” nothing more specific than “everything under the sun made by man”. The public is on notice then, that any broadening prosecution amendment is still going to be within the scope of the original “invention”. I see PCT WO docs coming out of the USA, these days, in which claim 1 is absurdly broad and in which the specification begins, at the top of page 1, with the sub-title “Brief Description of the Drawings”. Long years ago, there used to be a section in the specification headed “Summary of the Invention”. That’s long gone. We now have “Summary”. But now, even that’s gone. Come on judges, impose some discipline here. Borrow from Europe one more thing, namely a sensitivity to the mischief of prosecution amendments to originally undisclosed intermediate generalisations.

  29. 20

    On one of the other threads on this site about this case, Carmac asked: if the detailed description says that a feature of the invention has a spike, does this mean that there is no 112-1 support for a claim which does not include the spike?

    And I answered: I think this case, among others, stands for the [at-least-currently “unremarkable”] proposition that, when it comes to “the invention”, you can’t have it both ways.

    When the detailed description clearly asserts that “_the_ invention” (rather than simply some exemplary embodiments of “the invention”) “has” a “spike”, and the description is otherwise silent about any embodiments that have no spike, this case seems to say there is simply no room to later validly assert, via attempted prosecution or enforcement of a claim, that “_the_ invention” has NO “spike” after all.

    In other words, by making a clear assertion that “_the_ invention” (rather than a particular embodiment) “has” a “spike”, the applicant has effectively asserted to the public that every embodiment “must include” that “necessary” and “critical” “spike”.

    Otherwise, the public (i.e., competitors) must assume that the applicant is dishonest in its global and permanent characterizations of its “invention”, i.e., that the applicant means something other than what they clearly asserted. In that world, those competitors must remain diligently alert, year after year, for a late-emerging patent that suddenly lays claim to the misrepresented turf. Can’t say I blame the court for discouraging such shenanigans.

  30. 19

    Defector wrote: “It wasn’t that long ago that the written description presented “the preferred embodiment” and the claims defined the invention. It wouldn’t have mattered if the broadened claims encompassed subject matter not enabled, since you were only required to disclose one enabling embodiment. I think we’ve gone far off track.”

    This case is not about enablement. It is about possession. The application enabled many embodiments. But it did not possess (provide ANY written description of) any embodiment of “the invention” that lacked a “spike”. Moreover, the application insisted that, globally, “the invention” “has” a “spike”, clearly implying that no embodiment of “the invention” is without a “spike”.

  31. 18

    bsn: you make my point. Litigation ought to be a last resort. Anything else and the courts get overloaded with cases that should have settled ie all the ones that are not (in my terminology) 50:50 cases. Tell me: why is it that cases are coming to trial that are manifestly not 50:50. I’ll suggest an answer: it pays to litigate. What sort of a system is that then? One in which judges think that jury trials are a good thing, that are to be preferred over out-of-court settlements? Then again, it depends what we mean by 50:50. Maybe that means one thing in the USA and something different elsewhere. That’s OK too.

  32. 16

    “More sanctions would help. ”

    Sanctions against what, exactly?

    Mooney, are you still sleeping with Lumbergh?

  33. 15

    “I think we’ve gone far off track.”

    Which is no doubt for the best. There is no way you should be able to cover what you don’t enable.

  34. 14

    And Max, your one-in-four analysis is faulty. It is only correct if all of the 50/50 ‘hard’ cases are 50/50 on both validity and infringement. This is not usually the case.

  35. 13

    No, Steve. You need to have drafted your specification in such a way that the new embodiments fall within a POSITA’s understanding of what you said you’ve invented. You can then put in valid claims to capture the infringment. At this point it doesn’t matter whether that’s by way of amendment or by addition of new claims.

  36. 12

    “Rather, in Gentry, we applied and merely expounded upon the unremarkable proposition that a broad claim is invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope.”

    Today this is an unremarkable proposition. It wasn’t that long ago that the written description presented “the preferred embodiment” and the claims defined the invention. It wouldn’t have mattered if the broadened claims encompassed subject matter not enabled, since you were only required to disclose one enabling embodiment. I think we’ve gone far off track.

  37. 11

    …so if you’d like to claim some embodiment(s) of your invention that others have “come up with” during your prosecution, you’d best try to literally capture it/them by filing new claims/ continuation(s); leaving your originally-filed claims alone?

  38. 10

    Reposting from other thread on same case:

    Although Judge Moore did not mention the “critical element” or “essential element” doctrine of Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998), perhaps there is good reason.

    “In Gentry, the original disclosure identified the console of a sectional sofa as the only possible location for the controls. 134 F.3d at 1479, 45 USPQ2d at 1503. We held that the asserted claims were invalid because the location of the recliner controls in the claims was not limited to the console. Id. at 1479-80, 45 USPQ2d at 1503-04. In reaching that conclusion, we stated: “[I]t is clear that [the inventor] considered the location of the recliner controls on the console to be an essential element of his invention. Accordingly, his original disclosure serves to limit the permissible breadth of his after-drafted claims.” Id. In so stating, we did not announce a new “essential element” test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements. Use of particular language explaining a decision does not necessarily create a new legal test. Rather, in Gentry, we applied and merely expounded upon the unremarkable proposition that a broad claim is invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. Id. (“[C]laims may be no broader than the supporting disclosure.”). There was no description or support whatever in the Gentry patent of the controls being other than on the console.” Cooper Cameron Corp. v. Kvaerner Oilfield Products, Inc., 291 F.3d 1317 (Fed. Cir. 2002).

    Sounds like there ain’t no “essential element”, “critical element”, or “omitted element” test.

  39. 9

    In Gentry the spec said in several places things like “In all contemplated embodiments of the invention, the controls are here.” The Fed Cir opinion relied on those spec passages. Not many patents include spec statements like that.

  40. 7

    In Gentry Gallery didn’t the inventor admit at trial that he did not consider alternative locations for the controls until he had seen the defendant’s design.

    In ICU there is no similar admission.

    Maybe that is the difference?

  41. 6

    Hmmm…. comes down to the definition of “essential,” doesn’t it? Functionally essential v. legally essential.

    A point on the spike was not functionally essential in the ICU case because the art devices don’t have points. (The scored membrane obviates the need for points.)

    However, all of ICU’s embodiments had points and so the Claim 9 was construed so as to make a point legally essential. In a sense, ICU strongly implied that the point was functionally essential because it’s entire disclosure had only pointed claims.

    But what is legally essential is what must be put in the claim and/or specification in order to avoid 1) rejection, 2) invalidation or 3) non-infringement.

    Here, disclosing non-pointed (pointless?) spikes in the specification and claim was legally essential to win on infringement. IOW “non-pointed” was a legally essential limitation, which ICU failed to disclose and claim. Ergo, they lost. Good call, IMHO.

  42. 4

    So are we simply saying that the Presumption of Validity is not what it was, and that courts are now as willing to find invalidity as non-infringement? In that case, think of a 2×2 matrix in which the four squares are 1) Valid and Infringed 2) Valid but not Infringed 3) judged within the scope, but claim invalid and 4) Invalid and anyway not infringed. Now assume that the only cases that go to trial are those where both sides still think they ought to win ie the hard cases. Of these 50:50 cases, patent owner gets to win, one time in four. Not the end of the world then, is it. In fact, that statistic (which one finds all over Europe and Asia) would demonstrate a perfect patent litigation system, right?

    Tyrone 10am in which thread please. I’m horrified that I’m now behaving like Hannibal Lecturer.

  43. 3

    Tyrone, the approach you describe is surely the correct one. The Federal Circuit has been pushing this methodology for some time and I believe that it is slowly sinking in. That said, we still see the occasional District Court judge (or worse, a panel at the appellate level) getting rolled on the fundamentals of claim construction.

    More sanctions would help.

  44. 2

    How about: it it’s not fairly within the scope of what you described, you can’t say you invented it, so your claims can’t cover it, so it can’t infringe and/or your claims are invalid.

    Personally, I think using “written description” and/or “added matter” to invalidate an unjustifiably broad claim that is literally infringed is preferable to reading unrecited elements into the claim to support a finding of non-infringement (I may be a bit off point there, because I’m not completely familiar with the cases).

  45. 1

    Sorry Dennis, but I can’t think of anything to say. Hope somebody else can think of something.

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