How to Protect a Product of Nature

Roslin Institute"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.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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