Friday, May 9, 2014

PATENTS - Clones not sufficiently distinguishable, as described in this application

The issue:
[T]he dispute here concerns the Patent and Trademark Office's (PTO) rejection of Campbell's and Wilmut's claims to the clones themselves, set forth in the ′233 application, titled Quiescent Cell Populations for Nuclear Transfer.
The ′233 application [filed in 1999 - ec] claims the products of Campbell's and Wilmut's cloning method: cattle, sheep, pigs, and goats. Claims 155 and 164 are representative:
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 Fed. Cir.'s reasoning: 
in Myriad, the Court held that claims on two naturally occurring, isolated genes (BRCA1 and BRCA2), which can be examined to determine whether a person may develop breast cancer, were invalid under § 101133 S.Ct. at 2112–13, 2117–18. The Supreme Court concluded that the BRCA genes themselves were unpatentable products of nature. 
[...]
Roslin contends that copies (clones) are eligible for protection because they are “the product of human ingenuity” and “not nature's handiwork, but [their] own.” Appellant's Br. 17, 18. Roslin argues that such copies are either compositions of matter or manufactures within the scope of § 101. However, Dolly herself is an exact genetic replica of another sheep and does not possess “markedly different characteristics from any [farm animals] found in nature.” Chakrabarty, 447 U.S. at 310; see Reply Br. 13 (stating that “the clones are genetic copies”). Dolly's genetic identity to her donor parent renders her unpatentable.
As for what Roslin could have done to claim patentable subject matter: 
 any difference in mitochondrial DNA between the donor and cloned mammals is, too, unclaimed. Furthermore, Roslin's patent application does not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals 
[...]
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. 

Because this was filed 

In re Roslin Inst. (Edinburgh), 2013-1407, 2014 WL 1814014 (Fed. Cir. May 8, 2014)

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