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« Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs | Main | Court Report »

January 28, 2016

Comments

Thanks for the update. This technology is indeed a big deal, but in view of the Sequenom decision, I wager that the PTO will wash its hand of all of this by ruling that all the claims at issue are directed to ineligible subject matter under 101.

Which Office rule mandates the 36 month time frame?

My brother "Cynical" would harumph and say that all of this is "directed to" a law of nature, add in a snippet of leaf-cutting, a magic microscope, and call it a day as he locks up the patent office doors on his way out.

;-)

Dear Doug:

It might be tough for that to stick, seeing how the reaction occurs in bacteria in nature and its application to mammals requires human intervention.

Historical note/correction:
Cohen and Boyer did not discover restriction enzymes. See .
Cohen and Boyer got the first patent for recombinant DNA, which was invalid because, among other reasons, the conception was by Peter Lobban and, independently, Paul Berg. See . Albert Halluin wrote an article on it. (Why the patent was never challenged ....)

good job! Kevin

"It might be tough for that to stick, seeing how the reaction occurs in bacteria in nature and its application to mammals requires human intervention."

Kevin,

You just call that human intervention activity "conventional" so the claim could still be determined to be patent ineligible under Alice-Mayo.


Thanks, Barry. As usual, things are not as simple as they seem.

Bacterial restriction was observed as early as the 1950's as a way that bacteria protected themselves from lambda virus infection. These enzymes, later termed Type I enzymes, were not useful for cloning or gene mapping because they cleaved at a relatively random position some distance from the recognition sites.

Ham Smith and Dan Nathan were the first to identify the Type II enzymes, including EcoR1, and to use them to prepare a physical map of SV40 viral DNA. Paul Berg indeed was the first person to make a recombinant plasmid (and to trigger the need to the Asilomar conference to discuss the potential risks of recombinant DNA).

But Cohen and Boyer were the first to realize that restriction digestion + ligase treatment could provide an effective way to prepare recombinant DNA:

Cohen, S. N., Chang, A. C. Y., Boyer, H. W. & Helling, R. B. (1973) Proc. Natl. Acad. Sci. USA 70, 3240-3244.

All this was summarized nicely by Richard Roberts in PNAS:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1087929/

Thanks for giving me the opportunity to clarify.

Dear Rational:

I don't see producing the type of guide RNA in a non-bacterial cell combined with a bacterial nuclease as being conventional in any way.

I am pessimistic about overcoming Alice/Mayo but not despondent about it.

Thanks for the comment

"I don't see producing the type of guide RNA in a non-bacterial cell combined with a bacterial nuclease as being conventional in any way."

Kevin,

Based on the reasoning of Mayo, the court can, if it wishes, just keep subdividing the parts of the claim until the sub-parts are each either conventional or directed to laws of nature. For example in Alice, the step of determining whether the level of 6-thiouguanine was less than or below a particular amount was subdivided so that the act of determining could be classified as separate "conventional step" and the particular level could be held to be a separate "step" directed a "law of nature."

Of course, the court in Mayo improperly held that the two wherein clauses were two separate "wherein steps" and not part of the determination step (b).

Also, under the holding of Myriad, DNA, despite all evidence to the contrary, is just "information" and not a physical molecule. Also, based on the holding of Myriad, despite all evidence to the contrary and despite what has been taught in chemistry classes around world for decades, breaking two covalent bonds in a first molecule to produce a second molecule DOES NOT produce a second molecule that is different from the first molecule.

From Myriad:

"Also, based on Myriad, any step that involved breaking a covalent bond at a particular place in a molecule involved the "conventional step" of breaking the covalent bond.

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA."

The scientific ignorance of the Supreme Court is breathtaking.

The last part of my previous post should have read:

Also, based on Myriad, any step that involves breaking a covalent bond at a particular place in a molecule involves merely involves "conventional step" of breaking the covalent bond and therefore cannot be used as a basis for patent eligibility.

From Myriad:

"Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA."

The scientific ignorance of the Supreme Court is breathtaking.

@ A Rational Person

If you want to understand Myriad, it really pays to read Chakrabarty, American Fruit Growers and Hartranft.

By WHAT reasoning and jurisprudence does gBACA1 fall into the category "composition of matter" or "manufacture"? gBRCA1 may be a newly created molecule, but does that mean that it falls into either category?

To Mr. Cole's point, the act of "creation by man" is not enough.

Take purification of salt water into potable water as a loose example.

Pure water may be created (and for argument's sake, let's say that the process takes a vat of salt water, breaks that vat down to all of its elements, and then efficiently removes all elements except hydrogen and oxygen, which are then recombined into pure water).

Clearly, the final product is something made by man.

Also as clearly, that final product itself is not eligible for patenting.

Note that an argument to deny a patent that might be attempted to be uses might be 102, since pure water is known.

But that is a different "test" and in truth but an additional block (patentability as opposed to eligibility).

Now one may still (possibly) obtain a patent on the process, but the end item itself, although "technically" a manufacture according to any legal definition of that term, remains outside the realm of eligibility precisely because it is a manufacture that nature itself can make.

There is no difference in kind from what is in "the warehouse of nature."

Skeptical,

I understand that merely being "man-made" is not enough to make a product eligible if the product, such as pure water, exists in nature in the same form as the man-made product. But Mr. Cole is arguing that a new molecule that is formed by breaking covalent bonds and that does not exist in nature in its man-made form is not patent eligible. When has that ever been the rule before Myriad?

In your example of purifying water, even though you may be breaking down water in your purification process you are still ending up with water and salt at the end. The water and salt may now be separated, but they are still the same compounds with which you started, i.e., there are no "new" molecules being formed in your proposed process.

Also, if pure water did not exist in nature, and your process produced water of a purity that did not exist in nature and it was unobvious how to produce water of a particular purity, then it seems reasonable that you should be able to claim as a product water of particular purity. For example, see the following from MPEP 2144.04:

"Pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are unobvious over the prior art. In re Bergstrom, 427F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious."

@Paul

"By WHAT reasoning and jurisprudence does gBACA1 fall into the category "composition of matter" or "manufacture"? gBRCA1 may be a newly created molecule, but does that mean that it falls into either category??"

Claim 1 of U.S. Patent No. 5,747,282 at issue in the Myriad case reads as follows:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

The DNA molecule in Claim 1 was admitted by the court to be nonnaturally occurring. Therefore, the DNA molecule should have been found by the Supreme Court to be both a new composition of matter and a manufacture.

A Rational Person,

Thank you for thinking through the loose example.

Where the example becomes tighter (and why Myriad was decided as it was), are the spaces where you "effectively" have something already in nature's warehouse (note: this is not a time dependent 102 argument).

While Myriad's claim was to an isolated coding, that mere isolation itself was deemed to effectively be the same as the un-isolated coding because (to the Court's eye), the "Gist" (to borrow the term) of the isolated portion was EFFECTIVELY the same as the non-isolated portion. While in fact different, they were not different "enough."

That's my attempt at translating what the Court said anyway.

@Paul

The problem is for me is that there is no "isolation of DNA" exception to 35 USC 101 specifically spelled out in the statute. In the absence of such an explicit exception, a DNA molecule should have been treated as any other chemical.

When you break the covalent chemical bonds of a first DNA to form a second DNA molecule, the second DNA molecule is a different molecule than the first DNA molecule and has different properties than the first DNA.

This no different than breaking a covalent bond in ethanol, a drinkable alcohol and generally considered safe in limited quantities, to form methane (a gas) and a methanol (a liquid that is poisonous when drunk). If methane and methanol did not exist naturally, no chemist would consider them part of "nature's warehouse" because ethanol can be broken down to form them.

Also, the idea that the difference between the second and first DNA molecule is not "significant" or "different enough" is rebutted by the fact that that the party challenging the patents in Myriad was willing to spend the money to invalidate the patents. If the isolated DNA molecule was not significantly different than the full naturally occurring DNA molecule the people challenging parties could have simply used the full naturally occurring DNA molecule.

I think you give the Court too much credit with respect to their scientific knowledge and logical reasoning.

@Paul,

My apologies, my last post should have been

@Skeptical

A Rational Person,

I think that you have overstated the situation with your response.

Your counter example has a logical error, in that the example you have chosen does in fact make a difference in kind. Not all breaking of bonds has that same result, so you are attempting to make a logical leap that does not fit.

Further, your attempt to use the actual battle (and the "expense" or even "futility") of letting the challenger of Myriad's patent to use the "effective" other item - the so called item already in the warehouse of nature INSTEAD of the Myriad CLAIMED item is also a use of "false" logic.

Yes there is a difference, and yes, that difference does have real world effects. But those are just not the effects that the Court is looking at from a differentiating patent perspective.

(Again, do not "shoot the messenger" - this is just my take on what the Court stated)

What the Court did was to look at the (in)famous "Gist," and decide - based on that "Gist" whether "using the full molecule" or the claimed portion made ENOUGH of a difference for the aim of what that use was going to be.

Here, the answer was "no," as (again, as I take the Court's writing) EVEN using the full molecule, one would need to engage in (conventional) processes that would get to the same EFFECTIVE place as the claim in order to have the utility in question. Effectively, the "allowance" of the claim would mean that the full molecule you offer as an option would NOT be a viable option.

Personally, I think that your position has legs BECAUSE it shows that a specific utility - NOT found in nature - accompanies man's doing something with something found in nature. To me this is indeed "different enough."

Was this argument made? I do seem to recall that THAT answer is yes (even on this very blog).

Was that argument LISTENED to? Or, was there an Ends already in mind?

@Skeptical,

True, not all breaking of covalent bonds would produce a different material. For example in the case of a polymer or any compound with repeating units such as cellulose (remember the baseball bat "isolated" from a tree example during oral argument?) and some type of DNA and RNA molecules, when you separate out a portion of the molecule the new molecule formed is essentially the same material but a smaller piece.

But that wasn't the case with the isolated
DNA molecule in Myriad. And my concern is that no one on the Court understood the difference as well (see the baseball bat example during oral argument).

Your point about the theoretical false logic of the expense of the suit is well-taken. I am also no expert on the specific field of the patent and its economics. There was also a strong political component to this suit with amici (wrongly) concerned about patenting human beings and their DNA. But I would still guess that from a practical point, people in this field would believe there was a significant different in working with the isolated DNA molecule instead of the full DNA molecule.

I also don't think it's just a case of arguments not being listened to by the Court. I think it's also a case that they just do not understand basic chemistry.

For example, I would not be surprised that if an attorney ever based an argument on the analogy that iron loses weight as it rusts that at least one member of the Supreme Court would buy this erroneous analogy (in fact, as has been known for centuries now, iron gains weight as it rusts by reacting with oxygen to form iron oxide).

Comment noting the allowance to play with human embryos by UK scientists using CRISPR...

Stuck in moderation...?

Too "sensitive" to post...?

Skeptical:

All of the comments we have received in the past week have been published. You will have to re-send your earlier comment.

Don

Sorry Don, did not save the comment.

If I recall correctly, the comment was noting a certain lack of ethical concern tangent to this article in that recently, the UK has approved "playing" with human embryos using the CRISPR technology.

The article I read did not detail any limits as to the grant to use CRISPR on the human embryos, and visions of the Island of Doctor Moreau danced in my head.

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