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« Patent Profile: Ryogen Announces Issuance of Two Genomics Patents | Main | Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement »

April 13, 2009

Comments

Hold on now. I thought we were still in the "unpredictable arts such as chemistry and biology" world. Thank God now Kubin will save me from ever getting another one of those bogus enablement rejections based on case law that's now 15 years old.

Oh wait. The PTO will have its cake and eat it, too. I forgot. Never mind.

Why isn't Valiante's mention of NK cell library not enough for obviousness? Skilled artisans working with immune cells necessarily know that to get a decent amount of mRNA, one needs to activate them. Matthew, even though with mouse, fills that gap. I agree with your overall analysis, but there cannot be a bright-line rule that designates all cDNAs as obvious or non-obvious if a partial amino acid sequence and a possible method of isolation is known. I am not convinced of the 10e36 argument. If there is a specific DNA probe, let's say 21 bp, it is sufficient to pick out the full-length target of 1000 bp even though there may be 10e36 combinations. I don't think KSR prevents someone from doing a one-step experiment to reduce the possibilities to being finite.

Dear SK:

As far as I know, there was no teaching in Valiante or Matthew about activating the NK cells; I think (I could be wrong) that mouse cells may be different from human cells in that regard. And keep in mind that the art did not recognize that Matthew's 2B4 cDNA was NAIL, so the Board at least limited it use of Matthew to showing that following Valiante + Sambrook would predictably produce NAIL cDNA. If mouse cells and human cells have different activation requirements, then the human cDNA should be non-obvious because obtaining it, while maybe obvious to try would have met with unexpected results (i.e., not being able to obtain it following the prior art).

As for the Bell analysis, that was different from Deuel. There, the argument was that what was claimed was 1 out of 10^36 sequences, and the skilled worker would not have been able to predictably identify that specific sequence. Still seems like a proper distinction (and the claim scope is so narrow that it shouldn't pose problems for the "promote the progress" crowd - indeed, since the claim doesn't cover anything but the sequence, it enables the skilled worker to produce any other sequence without (literal) infringement).

I also agree that there should be a bright line rule - indeed, Deuel was a reaction against another PTO per se obviousness determination (protein known in the prior art + Sambrook = obvious). I think there may be situations where the result is so predictable (something which has become more likely in the time since Deuel due to technology improvements) that it may be obvious because 1) it is obvious to try and 2) the level of predictability makes what is obvious to try also obvious. I think what Judge Lourie was saying in Deuel was that JUST because something is obvious to try doesn't mean it is necessarily obvious. Of course, O'Farrell stands for the reasonable proposition that sometimes something that is obvious to try is also obvious, and KSR sets forth the Supreme Court's delineation of when that "sometimes" applies - a small number of known alternative solutions to a recognized problem that perform as expected by the skilled artisan.

The PTO's problem is that they consistently applied these rubrics to the method rather than the composition - the cDNA - claimed. Which is what Deuel stands for, not as a bright line rule but as the antidote to a PTO bright line rule.

Thanks for the comment.

Dear Bill:

The PTO always eats its cake and has it too, but sometimes the chickens come home to roost (see posts about 10% reduction in applications and massive shortfalls in funding due to lower allowance rates, higher abandonment rates and fewer maintenance fee payments).

The pendulum will swing back, and soon I suspect.

Thanks for the comment.

You say: Knowledge commensurate with Bell limits the scope of any claim for a gene encoding the protein to the specific nucleotide sequence of the isolated cDNA. Non-obviousness on these grounds is Federal Circuit precedent from the Bell case, and neither Kubin nor KSR International Co. v. Teleflex Inc. overrules it...

I find that odd, a genus of nucleotides is obvious, but no particular one is? What exactly is within the possession of the public then? So Kubin could have just claimed each species separately?

I disagree, and I think that what is obvious under Kubin is the sequence found in Rader's cells, or maybe the sequences in available cultured cells, and that sequences other than that might be obvious.

Dear Grimace:

It is frequently the case that a species is non-obvious over a genus, provided that it embodies an unexpected result. Here, it would be that out of the 10^36 possible sequences, the one Bell claimed was the "human" sequence.

From a chemical context, a species anticipates a genus, and since anticipation is the epitome of obviousness it is consistent that a different species would not be obvious, absent any reason the skilled artisan would have had to choose that species.

Certainly one of the problems in Kubin was the breadth of the claims (although written description provided a better ground for findng the claims invalid).

Thanks for the comment.

Kevin

I understand that a given species might be patentable over a genus. What I don't understand is when EVERY species is patentable over a genus.

Is the fed cir telling patentees to crank out the permutations and pop in a ridiculous markush? The reasoning articulated above leads one there.

Dear Grimace:

That was the objection in the Gleave case (for different reasons).

I think the link is the "surprising and unexpected" result that Bell's 1 nucleotide sequence (out of the 10^36 possible sequences) was "the" human sequence. So that a further listing of alternative sequences, without more, would not get the non-obvious determination.

Thanks for the comment.

Kevin: "This is because of the degeneracy of the genetic code: there are multiple codons for all but two of the 20 naturally-occurring amino acids, so the number of possible nucleotide sequences for any amino acid sequence is typically astronomical -- the number of possible nucleotide sequences that could encode the insulin-like growth factor in the Bell case was 1036 (for a protein encoded by 70 amino acids). Non-obviousness on these grounds is Federal Circuit precedent from the Bell case, and neither Kubin nor KSR International Co. v. Teleflex Inc. overrules it (unless 1036 can be considered a "small" number of predicable solutions)."

Did Kubin's counsel raise this obvious issue during prosecution?

Dear Keep:

Kubin's counsel was limited because their claim was the exact opposite: not only was it broader than Deuel (which was limited to a nucleotide sequence encoding a specific amino acid sequence) but it also included nucleotide sequences that were only 80% identical to the disclosed sequence (so 20 aas out of every hundred could be "non-identical").

A massive number of species. The only thing that saved them from Matthew is that the mouse NAIL cDNA was only 69% identical. So they couldn't argue that their claim was a Bell-like claim (and for some reason both the Board and the CAFC didn't discuss any of the narrower claims).

Short answer, no because it wouldn't have helped them.

Thanks for the comment.

Kevin:

Thanks for the reply. I think that many have given the method/composition distinction short shrift. The reliance on Sambrook is borderline laughable, in my honest opinion. So are we to assume that there will never be a patentable small organic molecule unless someone somehow comes up with a new synthesis scheme that is itself per se novel and non-obvious? That doesn't even pass the laugh test.

And taking it a step further, if the product is obvious, you can use the techniques described in Sambrook to express it in various cell types, so all the in vitro testing one might do is also obvious. And when you find a biological activity for the peptide/nucleic acid/whatever, whatever it might be is also merely obvious. Therefore, your method of use claims are also obvious.

The U.S. has been the world leader in the biotechnology game since its inception. Taking this opinion and its "logic" to its absurd extreme, which I argue the CAFC has already come very close to doing, runs the great risk of killing the industry off. You think it was hard to raise capital for a fledgling biotech recently? You ain't seen nothing yet.

"The pendulum will swing back, and soon I suspect."

You are right about that.

I haven't been able to go over all this quite yet since I just saw it. But, at a glance, I have to say this:

Kev, you realize that if the underlying facts are that complicated (and you are right, rather than wrong about the mouse reference, which from the above poster it seems like you're wrong) then Kubin should have made his case like you're doing rather than the weak attempts at high level reasoning that in no way support a finding of non-obviousness. The PTO only has to establish a prima facie case rather than a rock solid case. Kubin can always go to the DC and sue for allowance of his application, or he can file an RCE, explain all this, and get his claim allowed, and he can be more specific than you were in his explanation. Why do attorneys and applicants make conclusory statements/arguments just as often as examiners do? YOU HAVE TO SHOW THE FACTS IN THEIR ENTIRETY. Sure, the examiner may, or may not have understood all of this from the beginning, but maybe he wanted it all on the record before he just up and allowed the case. A prima facie case existed based upon the case before him n he wrote it down. The appeals court affirmed. According to your explanation, they all did their jobs 100% properly, and Kubin, or his attorney, did a miserable job. But, that's just what you say leads to. I'm not quite sure if the case could have been saved yet or not. It seems to me like, upon a glance, there are great many huge gaping holes in the factual case on either side, but Kubin doesn't highlight the holes on the PTO's side sufficiently or adequately in language. That's the applicant's job you know. 35 USC 132 iirc. Furthermore, the holes on the PTO's side might be filled by just general knowledge, but nobody talks about it if it is, so I can only presume that perhaps it is, and perhaps it isn't. But since nobody talks about it in the case specifically and adequately, the applicant's arguments would be unavailing it seems to me.

You'd be surprised the amount of times where the applicant does actually have a point or argument to make with regards to obviousness etc. but they choose to spout some incomplete nonsense or total nonsense in leiu of telling me all about it. Estoppel concerns maybe idk. Of course they get a final, and then they want to AF and get an allowance. Well, by then you're a bit late for any easy mercy, your facts/argument is going to have to be GREAT.

Now, I'll get to the merits of your argument later on.

Dear 6:

One of the things that people who don't do this for a living (i.e., people other than patent attorneys and examiners) don't realize is that frequently it gets pretty complicated. Examiners are limited by the time they get to perform the examination, and attorneys (believe it or not) are limited by budgets, and so it isn't surprising that the outcome, or even the process, isn't always perfect.

But as long as each side is trying to do their best (and avoids the temptation to turn the other side into "the enemy") what more can we do?

Thanks for the comment.

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