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In re Roslin Institute (Edinburgh)

Representative Claim(s)

155. A live-born clone of a pre-existing, non-embryonic, 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.

Posture:

Appeal from final decision of the Patent Trial and Appeal Board

Exception Category: Natural Phenomenon

Despite Appellant’s argument that the claimed clones were “the product of human ingenuity” and “not nature’s handiwork, but [their] own”, the court held that the clone was an exact genetic replica of a naturally-occurring sheep.  The court stated, “Dolly’s genetic identity to her donor parent renders her unpatentable.”

Significantly More: No

Appellant presented three arguments to assert patentability over naturally-occurring donor mammals:

  1. Appellant argued that the claimed clones were distinguishable from the donor mammals used to create them because of environmental factors that lead to phenotypic differences. The court first noted that such phenotypic differences were not claimed, and secondly that “any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee.’”  The court thus equated the asserted phenotypic differences to natural phenomena, which are not patentable.
  1. Appellant argued that the claimed clones were distinguishable from their original donor mammals because of differences in mitochondrial DNA. Again, the court noted that mitochondrial differences were not claimed.  Moreover, the court indicated that, “application does not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals” and that there was nothing in the application suggesting that the clones were “distinct in any relevant way from the donor animals of which they are copies.”
  1. Finally, Appellant argued that the claimed clones were “patent eligible because they are time-delayed versions of their donor mammals.” The court summarily affirmed the PTAB’s rejection of this argument on the basis that it would be true of any copy of an original.