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In re Roslin Institute

United States Court of Appeals, Federal Circuit

May 8, 2014

IN RE ROSLIN INSTITUTE (Edinburgh)

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Serial No. 09/225,233.

SALVATORE J. ARRIGO, Law Office of Salvatore Arrigo and Scott Lee, LLP, of Washington, DC, argued for appellant. With him on the brief was SCOTT M.K. LEE.

AMY J. NELSON, Associate Solicitor, United States Patent and Trademark Office, of Alexandria, Virginia, argued for appellee. With her on the brief were NATHAN K. KELLEY, Deputy General Counsel for Intellectual Property Law and Solicitor, and THOMAS W. KRAUSE, Associate Solicitor.

Before DYK, MOORE, and WALLACH, Circuit Judges.

OPINION

Page 1334

Dyk, Circuit Judge.

The Roslin Institute of Edinburgh, Scotland (Roslin) is the assignee of U.S. Patent Application No. 09/225,233 (the '233 application) and appeals from a final decision of the Patent Trial and Appeal Board (Board). The Board held that all of Roslin's pending claims--claims 155-159 and 164--were unpatentable subject matter under 35 U.S.C. § 101. The Board also rejected Roslin's claims as anticipated and obvious under 35 U.S.C. § § 102 and 103. We affirm the Board's rejection of the claims under § 101.

Background

On July 5, 1996, Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. A clone is an identical genetic copy of a cell, cell part, or organism.

The cloning method Campbell and Wilmut used to create Dolly constituted a breakthrough in scientific discovery. Known as somatic cell nuclear transfer, this process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated ( i.e., without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is a female gametocyte (an egg cell prior to maturation), and a nucleus is the organelle that holds a cell's genetic material (its DNA). Often referred to as " adult" cells, somatic cells are differentiated, i.e., they are specialized to perform specific functions. For example, liver, heart, and muscle cells are all differentiated, somatic cells.

To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. Specifically, Campbell and Wilmut found that if the donor, somatic cell is arrested in the stage of the cell cycle where it is dormant and non-replicating (the quiescent phase) prior to nuclear transfer, the resulting fused cell will develop into a reconstituted embryo. Once the nucleus of a somatic, donor cell is removed, that nucleus is fused with an oocyte, which develops into an embryo. The embryo can then be implanted into a surrogate mammal, where it develops into a baby animal. The resulting cloned animal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.

Campbell and Wilmut obtained a patent on the somatic method of cloning mammals, which has been assigned to Roslin. See U.S. Patent No. 7,514,258 (the '258 patent). The '258 patent is not before us in this appeal. Instead, the 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.[1]

Page 1335

The '233 application claims the products of Campbell's and Wilmut's cloning method: cattle, sheep, pigs, and goats. ...


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