Earlier today, the Federal Circuit affirmed a determination by the Patent Trial and Appeal Board affirming the rejection of claims 155-159 and 164 of U.S. Application No. 09/225,233 as being directed to unpatentable subject matter under 35 U.S.C. § 101.  Coincidentally, the decision comes on the eve of the U.S. Patent and Trademark Office's public forum on the Myriad/Mayo Guidance, which will take place from 1:00 to 4:00 pm (ET) on Friday.

The inventors on the '233 application, Dr. Keith H.S. Campbell and Sir Ian Wilmut, were the first to produce a cloned mammal from an adult somatic cell -- Dolly the sheep.  Dr. Campbell and Sir Ian obtained U.S. Patent No. 7,514,258 for the method they used to produce Dolly:  somatic cell nuclear transfer, which involves removing the nucleus of a somatic cell that has been arrested in the quiescent phase of the cell cycle and implanting that nucleus into an enucleated oocyte.  The '233 application, however, is directed to the product of the cloning method.  Representative claims 155 and 164 recite:

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

164.  The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

The Examiner rejected the claims at issue as being directed to non-statutory subject matter under 35 U.S.C. § 101, and as being anticipated and obvious under §§ 102 and 103.  The Board affirmed the Examiner's rejections, finding that the claimed subject matter was ineligible for patent protection under § 101 because it constituted a natural phenomenon that did not possess "markedly different characteristics than any found in nature."

In affirming the Board's affirmance of the Examiner's rejections, the Federal Circuit begins by noting that "[e]ven before the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), the Court’s opinions in [Diamond v.] Chakrabarty [447 U.S. 303, 309 (1980),] and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), made clear that naturally occurring organisms are not patentable."  With respect to Funk Bros., where the claimed invention was directed to a mixture of naturally occurring strains of bacteria that helped leguminous plants extract nitrogen from the air and fix it in soil, the opinion indicates that "while the method of selecting the strains of bacteria might have been patent eligible, the natural organism itself -- the mixture of bacteria -- was unpatentable because its 'qualities are the work of nature' unaltered by the hand of man."  In Chakrabarty, however, a genetically engineered bacterium that was capable of breaking down various components of crude oil was found to be patent eligible because "it was 'new' with 'markedly different characteristics from any found in nature and one having the potential for significant utility."  From these two cases, the Court concludes that "discoveries that possess 'markedly different characteristics from any found in nature' are eligible for patent protection [and] any existing organism or newly discovered plant found in the wild is not patentable."

On appeal, the Roslin Institute argued that unlike the donor sheep used to create Dolly, clones like Dolly are eligible for protection because they are "the product of human ingenuity" and "not nature's handiwork, but [their] own."  The Court disagreed, stating that "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."  Analogizing the instant case to Myriad, the opinion states that:

Roslin "did not create or alter any of the genetic information" of its claimed clones, "[n]or did [Roslin] create or alter the genetic structure of [the] DNA" used to make its clones.  Myriad, 133 S. Ct. at 2116.  Instead, Roslin's chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken.  Such a copy is not eligible for patent protection.

The Roslin Institute also argued that its clones should be patent eligible because they are distinguishable in at least two respects from the donor mammals used to create them.  In particular, the Roslin Institute argued that:  (1) environmental factors lead to phenotypic differences that distinguish the clones from their donor mammals, and (2) the clones are distinguishable from their original donor mammals because of differences in mitochondrial DNA, which originates from the donor oocyte rather than the donor nucleus.  In response to both arguments, the Court noted that neither the phenotypic differences nor the differences in mitochondrial DNA were claimed.  Moreover, with respect to the phenotypic differences, the opinion indicates that "Roslin acknowledges that any phenotypic differences came about or were produced 'quite independently of any effort of the patentee.'"  Thus, "[such] phenotypic differences do not confer eligibility on their claimed subject matter [because a]ny phenotypic differences between Roslin's donor mammals and its claimed clones are the result of 'environmental factors,' uninfluenced by Roslin's efforts" (citation omitted).

The Court did appear to leave the door slightly ajar for other cloned animals, stating that:

There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies.  The clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals.  To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.  Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.

As a result, the Federal Circuit affirmed the Board's finding that the Roslin Institute's clones constitute unpatentable subject matter under § 101.

In re Roslin Institute (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Moore, and Wallach
Opinion by Circuit Judge Dyk

Image of Dolly in her stuffed form (above) by Toni Barros, from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 2.0 Generic license.