On that basis, perhaps the ACLU is making the same kind of argument regarding the claimed process with regard to the genes. I really don’t know. But that seems to be the issue that some people are trying to get at, and others are either missing or avoiding.

The blanket statement of the issue whether the patents cover the gene itself does seem to be overreaching, without further explanation of the rule that is the preemption doctrine, at least a brief analysis, and how it migh be possible to draw that conclusion. But an issue like this one deserves more in depth analysis, rather than a simplistic observation that the claim is directed to a process, and not to a gene sequence.

You think a court will address the alleged “underlying, colorable constitutional questions” when statutory mechanisms for determining whether or not the claim is patentable or not already exist?

You cannot even reach your alleged constitutional questions until you address the patent question (i.e., what is being claimed), which is a question of claim construction. The Federal Circuit will eventually take on any case involving an issue of claim construction, so no matter what happens on this level, this case dies at the Federal Circuit. I hope you don’t harbor any hopes that SCOTUS will overturn the Federal Circuit’s/USPTO’s clam construction of the term “isolated DNA coding,” which is the only way this case will turn out any differently. If, by some remote chance, SCOTUS does happen to overturn the claim construction, then the patent gets invalidated under 102, and your constitutional issues never get addressed.

A big f’ing waste of time and money. Of course, all of this could be done for publicity purposes only with no expectation of winning the case. If so, then Rule 11 sanctions are definitely warranted.

An isolated gene is not found in nature. It is found as part of a chromosome and is inside a human cell. Myriad did not file for a patent on isolated version of any gene it filed for a gene that indicates a propensity to breast cancer. Myriad would not be entitled to a patent for an isolated a random gene. Your analogy to a Raven’s liver is exactly this situation of a patent to a random isolated gene, since you have provided not utility for having isolated a Ravens’s liver. Thus, under 35 USC 101 it is not patentable. But, clearly an isolated gene that shows a propensity to breast cancer is useful and is not found in nature.

By the way, it appears that it would be simple to design around the isolated BRCA1 gene, since we know the genes next to the BRCA1 gene. By isolating part of the adjacent genes with the BRCA1 gene you should avoid the claim that Mr. Koepsell is so concerned about. While I am not an expert on genetics, this would appear to be fairly easy to accomplish.

I wonder if Mr. Koepsell agrees with that in his heart (“I think that it is obvious how to isolate both ravens’ livers and genes, given the fact that nature has conveniently defined their borders.”)

Poor ACLU.

That’s the best you can do?

The claim construction issue had already been decided — by the USPTO dozens or hundreds of time (depending upon how many similar patents have had similar claims issued).

However, if you believe there is a claim construction issue that would raise a “a substantial new question of patentability,” then file for a request for reexamination under 35 U.S.C. 303(a).

Like most misguided attempts to show that claims are not patentable under 35 U.S.C. 101, these issues are best decided under 35 U.S.C. 102/103.

I think that it is obvious how to isolate both ravens’ livers and genes, given the fact that nature has conveniently defined their borders. I appreciate your help.

best,
David

I suspect your analogy does not hold, though, since I bet the gene(s) in question were not known, isolated or not… or if they were known, then 3) above would distinguish it from your 2) ravens’ livers analogy. It seems to me these are basic principles that (if you’re dabbling in this field) you should already understand. (If you don’t understand them already, then I suspect you can help the patent system exactly as much as our former Director Jon Dudas with zippo patent experience helped the patent system…. Yes, the saying holds, Mr. Koepsell, fool me once….)