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June 2, 2009

Outside the Membrane

Amgen and Ariad got into a tussle over 6,410,516. Ariad started with a DJ action, asserting invalidity and noninfringement. Amgen counterclaimed infringement. '516 claims reducing a specific protein's activity (NF-kB). The claim construction crux was whether the claimed activity occurred outside a cell, inside, or it didn't matter. But of course it mattered.

Amgen et al v. Ariad et al (CAFC 2009-1023) non-precedential

The '516 patent proposes several classes of molecules potentially capable of reducing NF-kB activity, such as specific inhibitors, dominantly interfering molecules, and decoy molecules... These classes of molecules are meant to act inside the cell... In contrast, the accused drug--Amgen's Enbrel--acts outside the cell. Enbrel acts by binding to free TNF-a outside the cell, thus interfering with the TNF-a's ability to reach the receptors on the cell and induce NF-kB activity... The prior art also contains example agents that act outside the cell. For example, antibiotics act by killing bacteria, which consequentially reduces the amount of TNF-a released by macrophages in response to the bacterial infection. The use of decoy molecules, Enbrel, or antibiotics all may ultimately result in a decrease of NF-kB activity, but the question remains what is included in the properly interpreted scope of "reducing NF-kB activity in cells."

The district court agreed with Amgen that the asserted claims are limited to actions that reduce NF-kB activity wherein those actions occur within the cell.

Amgen prevailed in the district court by arguing that the outer boundary of the asserted claims' scope is the cell membrane. The district court agreed with Amgen that agents that act outside the cell do not infringe, but that agents that act inside the cell may.

Ariad tried to fudge where the boundary might be.

Rather, Ariad would place the boundary at some indefinite place outside of the cell such that accused drugs such as Enbrel are captured but certain prior art drugs, such as antibiotics, are left out of the claim scope.

Case law over the cell call -

"Claim terms should generally be given their ordinary and customary meaning and . . . 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.'" ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368, 1374 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc)). "[T]he 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." Phillips, 415 F.3d at 1313; see id. at 1317 ("It is therefore entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims."). Furthermore, "the prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

The specification was dispositive.

The specification of the '516 patent divides external influences (e.g., TNF-a) and intracellular transducers (e.g., NF-kB). That division is at the cell membrane, and the claim language "reducing NF-kB activity in cells" is consistent with this division.

Thus, the specification assumes the existence of an external influence whose effect can be modified by acting within the cell. In contrast, Enbrel acts to stop the external influence (TNF-a) from reaching the cell.

Arguments made during reexamination "further reinforced the division between actions taken inside and outside of the cells."

Affirmed. Not even close.

Posted by Patent Hawk at June 2, 2009 10:23 PM | Claim Construction


On a completely unrelated note, Hal Wegner has penned a brilliant piece on the "Credibility of Patent Blogs"


...a quote "It is particularly damaging to credibility to post comments of a highly negative nature with no basis in fact, sometimes as part of a scatological rant."

He must be referring to the Mooney charade over at Patently-O.

Posted by: On an unrelated note at June 3, 2009 12:31 AM

While I have a great deal of respect for Hal Wegner, I just disagree with him on this point:


It is one thing to be critical of issues and the positions or qualifications of public officials. By entering the public arena, a person leaves the friendly confines of “private citizen” to become a “public figure” who should have their positions and qualifications scrutinized.


So private citizens can't express their opinion in a public forum? Only people with "qualifications" (whatever that means) can have opinions of any merit? This is elitism at its finest. Run along little people, Big Hal doesn't have time for you or your opinions.

I agree with Hal completely on the annoying individuals and other degenerates that add noise and shed little light the issues at hand. I almost completely stopped reading Patently-O a long time ago, and that was a primary reason for doing so.

Posted by: Defector at June 3, 2009 8:15 AM

While we are all guilty, myself included, of straying off topic from time to time and, nay, even waxing a little scatological, its the constant negative, scatological drumbeat (patents are crap, poo poo, doo doo) of characters like Mooney, who, most probably, in my opinion, is played by Dennis (how very, very, sad), that really have a way of ruining sensible dialog in our profession.

Incidentally, am very curious why Dennis left MBHB.

To Defector,

You seem to have really missed Hal's point. He is saying that once you leave the comfort of life as a private citizen, you should reasonably expect to have your qualifications scrutinized. However, the scrutiny should be objective, and limited to things like your qualifications for the job and not scatological rants like, Aharonian's characterization of Dave Kappos' nomination to head the PTO as "you might as well put Bernie Madoff in charge of the SEC."

Posted by: Just sayin' at June 3, 2009 5:02 PM

I just read Wegner's piece. Is the "credibility of a blog" based on the text of the actual blog posts, the comments, or both?

Also, some bloggers (and perhaps Mr. Wegner as well) seem to want to elevate blogs to a level of credibility on par with peer-reviewed academic journals. Don't get me wrong, I respect a good portion of what the bloggers write, and enjoy reading them. But, peer-reviewed journals they are not.

Posted by: kk at June 3, 2009 5:54 PM

"...lest you be judged by your peers"

Posted by: someone said... at June 3, 2009 6:21 PM

Hal seems to be saying that the negative and scatological rants can take away from the credibility of the entire blog and even the greater blogosphere.

In my opinion, Hal's piece is a call to patent blog sponsors (authors) who want to be taken seriously to more carefully police the content of their blogs (articles and comments) lest they lose credibility in the eyes of the greater profession.

I once admonished Dennis to register posters on PatentlyO limiting them to registered attorneys - or at least having an identifiable class of posters who were willing to post as registered attorneys. At that time, Dennis did not have a reg number so it is not surprising that he ignored my suggestion. However, it seems to me it would benefit the credibility of his blog and any other blog, if readers could distinguish between comments from registered practitioners, and comments from angry, gay, anti-patent, hacks like Mooney. Or at least just anti patent hacks, angry, gay or otherwise.

"some bloggers (and perhaps Mr. Wegner as well) seem to want to elevate blogs to a level of credibility on par with peer-reviewed academic journals"

Actually, its some of the blog authors themselves who want to elevate themselves to the level of peer reviewed academic journals, e.g. Dennis citing his own blog in his articles. But you are correct; blogs are not at the level of academic journals as much as they may want to be. Its kind of like an Examiner citing Wikipedia.

Hal seems to be saying that if blog authors want to be taken seriously, they need to stop posting scatological rants anonymously in the comments section under names like Mooney, BigGuy, LeopoldBloom, or whoever else is in the puppet show lineup of the week or allowing such posts to remain.

Posted by: Just sayin' at June 3, 2009 9:19 PM

Who's Hal Wegner?

Posted by: And Why Should Anyone Care at June 3, 2009 10:31 PM

Just sayin',

Isn't part of the overwhelming popularity of Patently-O the train-wreck factor? You KNOW that the likes of Malcolm, 6, and MaxDrei (sorry Max) will post their utter nonsense and actually believe their own scat. It's the patent-soap opera.

Even on Gene Quinn's blog, which tends to be at a higher level, Gene quickly admits that he is not a journalist and blogs on what he is passionate about. Such emotions naturally diminish logic and reason, even (especially?) in a law forum.

Do you expect a call to integrity (by the likes of either Hal Wegner or amusingly by Malcolm Mooney) to have any effect? Exclude the awful Noise, and it would be awfully quiet.

Posted by: Noise above Law at June 4, 2009 2:39 AM

Noise, you apologise to me, then 3 words later describe what I write as "utter nonsense". What am I supposed to make of that juxtaposition? Whatever, I'm grateful for the nod in my direction and for the education. The next time an American describes my work product as "scat" (I looked it up. Greek: Skatos) I will know something more about what's squatting, between that person's left and right ears.

Posted by: MaxDrei at June 4, 2009 8:07 AM

WTF is Hal Wegner and why should I care ?

Scatological ???

They print those patents on hard paper - makes them unsuitable for wiping your ass
that would be the only use of my patent right now

Right to exclude others ? Ha-ha-ha-ha-......

Posted by: angry dude at June 4, 2009 8:44 AM


My apologies were for listing your name along with the likes of Malcolm and 6. You are in a different class and deserve better company.

However, your techniques and postings are indeed often excrement, as you choose to purposely conflate EP and US law principles and engage in a scandalizing-post-and-watch-the-fallout mode and/or glorify the EP practice ad nauseum, which is indeed part of the train-wreck phenomena at Patently-O. Unitl you can control those tendencies, much of what you post is utter nonsense.

Posted by: Noise above Law at June 4, 2009 8:57 AM

Just sayin' wrote:

You seem to have really missed Hal's point. He is saying that once you leave the comfort of life as a private citizen, you should reasonably expect to have your qualifications scrutinized. However, the scrutiny should be objective, and limited to things like your qualifications for the job and not scatological rants like, Aharonian's characterization of Dave Kappos' nomination to head the PTO as "you might as well put Bernie Madoff in charge of the SEC."

Why do I suddenly leave the comfort of life as a private citizen when I post on a blog? Even if I used my real name, I am still posting as a citizen. After all, I don't have authority to speak for my employer or any association to which I belong. I would be forced to provide all sorts of disclaimers etc., and really who wants to read that garbage? Look, there are many people in the industry with credentials out the wazoo, whose opinions are hightly suspect (I'm looking at you, Mark Lemley), and yet there are independent inventors, examiners, public searchers (e.g., Greg Aharonian, the Patent Prosepctor, etc.) who's opinions are valuable contributions to the dialog, regardless as to whether you agree with them or not.

Greg Aharonian -- I have a great deal of respect for him but that doesn't mean I agree with him all the time. In general, he has legitimate criticisms, he is just sensationalistic, bombastic, inflammatory in expressing them. After subscribing to his news letter since I was an Examiner in the early to mid 1990s, I have become quite immune to his style. The guy is high on pot half the time anyway (I am assuming); God love him. But at the end of the day he is fighting in the only way he knows how for a better patent system, stronger patents, better examinations, more respect for examiners both within and outside of the PTO, more accountable PTO management. All the things I would like to see. I have found him generally respectful to others except elites like Kappos in the patent industry that in his eyes have made matters worse over the last decades. I don't know enough about Kappos really to have an opinion on the matter, but I endorse whole heartedly allowing him to express his views in forums like Patently-O and the Prospector.

I would like to see fewer flame wars, ad hominem attacks, etc. But at thes ame time I don't want to see any patent blog limiting comments to attorneys or agents. There are legitimate interested parties outside our legal profession, and not all are out to flame the industry, as it seems many have devoted a good part of their lives to. Adding noise and confusion to what should be civilized debate. I don't know how best these problems should be mitigated.

Posted by: Defector at June 4, 2009 4:08 PM

Wow Defector (your new Delta House name is Defecator), I underestimated your ability to get the wrong message. Maybe reading comprehension is the problem.

Hal was simply referring to the likes of Kappos or any other candidate for appointment to the PTO having to withstand scatological rants on blogs and the resulting lack of credibility of the blogs.

What does that have to do with you or any other poster? Hint, when he said "private citizen" he wasn't talking about you. He wasn't even talking about those that post.

He was talking about his hope that a private citizen (e.g. Kappos) could legitimately have their qualifications (e.g. for PTO Director) scrutinzed without having to withstand scatological rants on patent blogs. And whether the credibility of those blogs is called into question as a result of the scatological rants.

Posted by: Just sayin' at June 4, 2009 10:53 PM

"Who's Hal Wegner?"

Apparently, Hal Wegner = Just Sayin'

Just Sayin', it's nice the way you propose that allowing scatological comments destroys one's credibility, then a few comments later you call Defector "Defecator". By your own hypothesis, doesn't that destroy your own credibility?

(I know, it's a little late for that)

Posted by: Jane at June 6, 2009 7:55 AM

Jane - you ignorant slut - (to quote Chevy Chase from SNL),

Are you riding in the back of the short bus with Defecator?

Embedded in those long things with words that we call sentences, you will struggle to find a place where I said anything about scatological comments destroying credibility except to paraphrase Hal for the benefit of Defecator (and, now, apparently you).

If its a little late for me, I suppose it is waaaay too late for you.

Posted by: Just sayin' at June 7, 2009 8:57 PM