How to Protect a Product of Nature

By Kevin E. Noonan --

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance.  After all, this isn't the first time the Patent Office pendulum has swung against patenting (Don Chisum's "No Patent and Trademark Office" remark is legend) and it's likely to swing back again.  But in the meantime, to do the best for their clients, patent professionals need to exercise their skills to get claims granted that do what claims are designed to do:  provide a competitive advantage that supports a sufficient return so that there will be investment for commercializing the technology.

An example of how this might be done comes from the Roslin case regarding claims to "Dolly," the "cloned" sheep (see "In re Roslin Institute (Fed. Cir. 2014)").  To recap, the patent application at issue, U.S. Patent Application No. 09/225,233, was related to granted U.S. Patent No. 7,514,258 that claimed a somatic cell nuclear transfer method for producing Dolly, involving removing a somatic cell nucleus that has been arrested in the quiescent phase of the cell cycle and implanting that nucleus into an enucleated oocyte.  The patent eligibility of these claims was not at issue; the claims in the '233 application, on the other hand, were directed to the product of this cloning method.  Claim 155 is representative:

155.  A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

The Examiner, PTAB, and the Federal Circuit determined that the claims of the '233 application were not patent eligible because, in the end, what was claimed was just a sheep (or a pig, or a cow or a goat) that was not "markedly different [from what is] found in nature."  "Dolly herself is an exact genetic replica of another sheep and does not possess 'markedly different characteristics from any [farm animals] found in nature,'" and thus, "Dolly's genetic identity to her donor parent renders her unpatentable," according to Judge Dyk's Federal Circuit opinion.

And of course, that is accurate:  while there are instances of recombinant animals that differ from naturally occurring animals (SCID mice comprising a human immunoglobulin genetic complement, cows that produce hormones in their milk, pigs used to produce human organs), the advantage of sheep like Dolly is their genetic homogeneity which, for an individual sheep is just a genetic complement like any other genetic complement in an individual.

Of course, the advantage of a sheep like Dolly is not in the individual sheep, but in the ability to produce a flock of sheep (or a herd of cattle or a tribe of goats or a drove of pigs), all of which have the same homogeneous genetic complement.  (It will be recognized that such a collection of genetically identical individuals also has disadvantages, being essentially the quintessence of an inbred population.)  There is also an advantage of perpetuating this genetic identity from generation to generation without the dilution of the genotype that is inevitable due to mammalian mating (not only from genetic mixing from mating but from recombination that occurs during the production of gametes per se).

This reality (and the advantages of this population and temporal genetic homogeneity) suggest how this technology can be claimed.  For example:

A flock (herd/tribe/drove) of sheep (cow/goats/pigs) wherein each member of said flock (herd/tribe/drove) has a genetic complement that is identical to every other member of said flock (herd/tribe/drove).

A flock (herd/tribe/drove) of sheep (cow/goats/pigs) having a genetic complement that is perpetuated identically in at least two successive generations.

The question, of course, is whether such claims have the value that the claims invalidated by the Federal Circuit in In re Roslin would have had if deemed patent eligible, i.e., claims to the individual sheep or other mammalian species.  Clearly that claim is directed to one mammalian individual whereas the claims proposed herein are directed to a plurality of individuals making up the herd, etc.  But while there can be value in perpetuating an individual prize bull by cloning (for example), there is even greater economic value in a plurality of such cloned animals.  And relying on the distinction between an individual and a herd provides the grounds for arguing that what is claimed is "markedly different [from what is] found in nature."

These suggestions are not meant to be exhaustive, but they are intended to illuminate a path by which patent practitioners, the "clever draftsman" bogeyman of the patent system according to Justice Breyer, can use the art of patent claiming not to procure exclusivity rights greater than an inventor deserves but to fashion the scope of the patent right to both pass muster under the heightened scrutiny that "products of nature" will be subject to (regardless of how the Office may modify the Guidances in response to public input) and provide meaningful (if not the most expansive) protection.  Which is pretty much all that we can ask.

Comments

[EG]

Hey Kevin,

How about also creating a "pod of whales."

[Skeptical]

A very real problem remains Dr. Noonan:

No matter what you advise NOW, the courts can move the goalposts LATER, blaming the "scriviners" for doing the exact job that you are now asking for. In other words, your "answer" is NO answer, because down the road the courts can simply decree it to be NO answer.

We really need to NOT play this game. We really do need to take a stand - do claims pass 101 as the statute is written or do they not?

How deep the rabbit hole of "implicit" will we allow the courts to dig? Which branch of the government gets to write patent law? After all, if the courts can "interpret" the law to bend the nose of wax into anything it may choose to want (that is, play the "policy" role that belongs to Congress if the general view is that "patents are too many" or "patents are too easy" or "patents are too broad" then why bother writing patent law in the first place?

I know you mean well - and somehow - in the short term - we as advocates for our clients need to keep pressing for protection for our clients, but when is enough, enough? Where do we draw the line?

Is this the peace for our time that we really want? Is this the peace for our time that we should - as advocates - accept?

Is this the peace for our time that will really provide the protection our clients deserve?

As to the last question and the advice you offer, well (unfortunately), I remain...

[Jim Dunn]

Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980) (Products of na- ture are not created, and “ ‘manifestations . . . of nature [are] free to all men and reserved exclusively to none’ ”)

Never mind the S.Ct?

[Kevin E. Noonan]

Dear Jim:

Depends on how you define a "product of nature" - and don't forget, the Chakrabarty opinion also says that a patent-eligible invention, even if alive, must show evidence of "the hand of man." Which a genetically identical flock would do (it doesn't occur in nature).

But of course you are right - the Supreme Court could disagree. But keep in mind that my herd claim is not that broad (depending on how you define "flock" or "herd" - the serially cloned prize bull avoids such a claim, for example.

Thanks for the comment.

[Skeptical]

Twins - all your "flock" does is change the number and that simply won't be a change in kind that the Supremes will support.

[Kevin E. Noonan]

Dear Skeptical:

Re: twins: maybe, maybe not - which is why it depends on definition and asserted utility.

The base problem is that the Court is asserting its authority to check Congress and the Executive from exercising the patent power outside its Constitutional bounds. For the Court, obsessed with the idea that patents can inhibit as well as provide incentives for innovation, permitting certain subject matter to be patented (even if Congress had enacted "everything under the sun made by man" into the statute) exceeds Congress's powers (putatively because patenting these things does not promote progress). So there is no easy fix, other than the other branches pushing back in how they interpret the Court's pronouncements (the problem with the current guidance is that it extends the Court's holdings far beyond what is necessary).

Until we can come up with a way to convince five Justices generally uninformed about patents, the patent system and patent law (who rely on precedent from their equally misinformed predecessors) that permitting patenting broadly promotes innovation (against a chorus of the IT community, physicians and their patients who would rather steal others' technology) we won't solve the present problem.

Which is why I suggest ways to avoid the most pernicious of the consequences of these decisions.

[Skeptical]

Dr. Noonan,

Don't get me wrong - I understand why you are suggesting what you are suggesting.

The problem, though, is as I point out: you are fighting a rear guard losing battle. The ways you suggest have ALREADY been decried by the Court as the handiwork of scriviners - and the Court has no compunction of LATER moving the goalposts and obliterating what you advocate for the NOW. Your advice is tantamount to wasting the client's money. I know that statement "hurts." I do not enjoy making that statement.

Re: asserted utility has already been nullified as patent justification by the Court. That's a stillborn argument. In fact (as I am sure that you grasp), having TOO MUCH asserted utility is what the Justices fear. And "artificial limits" - like fields of technology - are simply ignored in how the Justices go about seeing what it is they want to see. Lots of nowhere plans for nobody.

[In the trenches]

We all must remember that the guidelines do NOT mention "product of nature" but instead state a "natural product" is not patent eligible. This is very different and broader.

[Skeptical]

I do not see the difference that you see, In the trenches. Can you explicate?

[Kevin E. Noonan]

Dear Skep:

The alternative is to simply give up. I think that Justice Breyer was right, but 1) he doesn't do this every day, we do and 2) the Court will have a tough time justifying invalidity merely because some inked-stained wretch of a patent lawyer has drafted a claim consistent with the convoluted twists and turns of the law created by all this goal-post moving. But like I've said about the ACLU, if the Court wants to start invalidating patents one at a time (and has nothing better to do), who am I to stop them?

[In the trenches]

Dear Skeptical

Maybe you work for the PTO since they also do not see the difference, or more correctly acknowledge the difference. As a biologist the difference is easy to see. A “product of nature” is so just that, a product found in nature. However, a “natural product” is something composed of products that are “natural” not synthesized. Most things in the world are natural products, since they are composed of components from nature. For example, a specific DNA sequence that codes for insulin is a “product of nature”. However, if you break the nucleotides apart, you no longer have a product of nature but it is still a natural product. The mixture of nucleotides would be rejected under 101 as being a “natural product” and not patent eligible. You might say that the mixture of nucleotides would be patent eligible, but you would be wrong, since I have received a 101 rejection on a similar claim. Another example of “product of nature” versus “natural product” is carbon and iron versus steel. Carbon and iron are products of nature, but steel is a natural product (mixture of carbon and iron) and not a product of nature. Examiners are rejecting claims to natural products that are not products of nature.

[Skeptical]

Thanks for the distinction.

I would call your "natural product" something else if it is something that is not found as a total item in nature.

EVERYTHING is composed of products that are "natural" - there is NOTHING that we have - absolutely nothing - that exists outside of components of nature. I suggest instead you call your man-made products "Man-made products" as opposed to "natural products."

Perhaps you have seen the allusion to the natural components of electrons, neutrons and protons, that is often mentioned on other blogs? That logical construct fits your emphasis of distinction. Your emphasis thus draws to an illogical conclusion in the patent context, and interestingly, is the same illogical conclusion that is reached by the software is "maths" crowd when one considers that everything is "maths."

The ontological/philosophical error is quite analogous.