05/08/14

In re Roslin Inst.: Set of Claims Directed to Dolly the Cloned Sheep Fail 101 Post-Myriad


Category: 101 
 
 
 
 By: Jesus Hernandez, Blog Editor/Contributor 
 
 
TitleIn re Roslin Inst. (Edinburgh), No. 13-1407 (Fed. Cir. May 8, 2014).
IssueWhile Roslin does not dispute that the donor sheep whose genetic material was used to create Dolly could not be patented, 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.” [...]. Roslin argues that such copies are either compositions of matter or manufactures within the scope of § 101 [because of phenotypic and mitochondrial differences between the original and the clone].
In re Roslin Inst. at *7 (internal citations omitted, text added).
HoldingDolly 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 [...] (stating that “the clones are genetic copies”). Dolly’s genetic identity to her donor parent renders her unpatentable [because of it is indistinguishable from a natural occuring sheep, and because the asserted phenotypic and mitochondrial differences between the clone and the original are not claimed].
Id. (some citations omited; text added).
 
 
 
 
Procedural HistoryOn November 10, 2008, the examiner issued a non- final rejection of Campbell’s and Wilmut’s patent claims because she found that they were directed to non- statutory subject matter under 35 U.S.C. § 101 […] [The Board] concluded 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 re Roslin Inst. at *3-4 (text added).
 
 
 
Legal Reasoning (Dyk, Moore, Wallach)
Background
Claims at issueThe ’233 application 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, 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.

In re Roslin Inst. at *3.
Legal Standard[D]iscoveries that possess “markedly different characteristics from any found in nature,” […], are eligible for patent protection. In contrast, any existing organism or newly discovered plant found in the wild is not patentable. More recently, in Myriad, the [Supreme] 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 § 101. 133 S. Ct. at 2112-13, 2117-18. The Supreme Court concluded that the BRCA genes themselves were unpatentable products of nature.
Id. at 6-7 (text added, some internal citations omitted).
Analysis
Clone not Different From 'Naturally Occuring' OriginalIn Myriad, the Court concluded that “isolated,” naturally occurring DNA strands are not eligible for patent protection. 133 S. Ct. at 2111. Here, as in Myriad, 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.
In re Roslin Inst. at *7-8.
Phenotypic Differences Unclaimed, QuestionedA phenotype refers to all the observable characteristics of an organism, such as shape, size, color, and behavior, that result from the interaction of the organism’s genotype with its environment. A mammal’s phenotype can change constantly throughout the life of that organism not only due to environmental changes, but also the physiological and morphological changes associated with aging. However, these differences are unclaimed. […] Indeed, the word “cloned” in the pending claims connotes genetic identity, and the claims say nothing about a phenotypic difference between the claimed subject matter and the donor mammals. Moreover, Roslin acknowledges that any phenotypic differences came about or were produced “quite independently of any effort of the patentee.”
Id. at *9.
Mitochondrial Differences UnclaimedMitochondria possess their own DNA, which is distinct from the DNA housed in the cell’s nucleus. In the cloning process, the clone inherits its mitochondrial DNA from its donor oocyte, instead of its donor somatic cell. Therefore, Dolly’s mitochondrial DNA came from the oocyte used to create her, not her donor mammary cell. Roslin argues that this difference in mitochondrial DNA renders its product claims patent eligible. But 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.
Id. at *10-11.
Conclusion
Thus, we affirm the Board’s finding that Roslin’s clones are unpatentable subject matter under § 101.
In re Roslin Inst. at *11-12.
 
 
 
 
 
 
 
 
 
 
 
 
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