In re Institution

• Decision Date: 12 August 2014
• Docket Number: No. 2013–1407.,2013–1407.
• Citation: 750 F.3d 1333
• Parties: In re ROSLIN INSTITUTE (EDINBURGH).
• Court: U.S. Court of Appeals — Federal Circuit

750 F.3d 1333

In re ROSLIN INSTITUTE (EDINBURGH).

No. 2013–1407.

United States Court of Appeals, Federal Circuit.

May 8, 2014.

Rehearing En Banc Denied Aug. 12, 2014.

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.

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. SeeU.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

The '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.

J.A. 4. As the Board described, “[c]laims 156–159 depend from claim 155 and further specify that the claimed clones are limited to clones of cattle, sheep, pigs, and goats, respectively.” J.A. 4.

On November 10, 2008, the examiner issued a nonfinal rejection of Campbell's and Wilmut's patent claims because she found that they were directed to nonstatutory subject matter under 35 U.S.C. § 101 as well as anticipated and obvious under §§ 102 and 103. On February 7, 2013, the Board affirmed the examiner's rejection of all of Campbell's and Wilmut's claims. Although the Board acknowledged that the claimed clones “may be called a composition of matter or a manufacture” as required by § 101, J.A. 18, it 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.” J.A. 21.

The Board also affirmed the examiner's finding that Campbell's and Wilmut's claimed subject matter was anticipated by and obvious in light of the relevant prior art under 35 U.S.C. §§ 102 and 103. Specifically, the Board explained that “ ‘[w]here ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.’ ” J.A. 21 (quoting In re Best, 562 F.2d 1252, 1255 (CCPA 1977)) (alteration and omission in original). The Board then held that the claimed clones were anticipated and obvious because they were indistinguishable from clones produced through prior art cloning methods, i.e., embryotic nuclear transfer and in vitro fertilization.

We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A). We review the Board's legal determinations de novo, and its factual findings for substantial evidence. In re Baxter Int'l, Inc., 678 F.3d 1357, 1361 (Fed.Cir.2012). Section 101 patent eligibility is a question of law that we review de novo. Bancorp Servs., LLC v. Sun Life Assurance Co. of Can., 687 F.3d 1266, 1273 (Fed.Cir.2012).

Discussion

I

An inventor may obtain a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” 35 U.S.C. § 101; see Bilski v. Kappos, 561 U.S. 593, 130 S.Ct. 3218, 3225, 177 L.Ed.2d 792 (2010). An invention that falls within one of these categories of patentable subject matter may still be ineligible for patent protection if it meets one of three exceptions. Laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., –––U.S. ––––, 132 S.Ct. 1289, 1293, 182 L.Ed.2d 321 (2012); Bilski, 130 S.Ct. at 3225;Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980); Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972); O'Reilly v. Morse, 56 U.S. (15 How.) 62, 112–20, 14 L.Ed. 601 (1854).

Even before the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., ––– U.S. ––––, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013), the Court's opinions in Chakrabarty and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S.Ct. 440, 92 L.Ed. 588 (1948), made clear that naturally occurring organisms are not patentable.

In Funk Bros., the Supreme Court considered a patent that claimed a mixture of naturally occurring strains of bacteria that helped leguminous plants extract nitrogen from the air and fix it in soil. 333 U.S. at 128–29, 68 S.Ct. 440. The Court concluded that this mixture of bacteria strains was not patent eligible because the patentee did not alter the bacteria in any way. Id. at 132, 68 S.Ct. 440 (“[T]here is no invention here unless the discovery that certain strains of the several species of these bacteria are non-inhibitive and may thus be safely mixed is invention. But we cannot so hold without allowing a patent to issue on one of the ancient secrets of nature now disclosed.”). Critically, in Funk Bros., the Court explained:

[w]e do not have presented the question whether the methods of selecting and testing the non-inhibitive strains are patentable. We have here only product claims. [The patentee] does not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable. For patents cannot issue for the discovery of the phenomena of nature. The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.

Id. at 130, 68 S.Ct. 440 (citation omitted). Thus, 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. Id.

In Chakrabarty, the Court clarified the scope of Funk. The patent at issue in Chakrabarty claimed a genetically engineered bacterium that was capable of breaking down various components of crude oil. 447 U.S. at 305, 100 S.Ct. 2204. The patent applicant created this non-naturally occurring bacterium by adding four plasmids to a specific strain of bacteria. Id. at 305 n. 1, 100 S.Ct. 2204. Overturning the Board's rejections, the Court held that the modified bacterium was patentable because it was “new” with “ markedly different characteristics from any found in nature and one having the potential for significant utility.” Id. at 310, 100 S.Ct. 2204 (emphasis added). As the Court explained, the patentee's “discovery is not nature's handiwork, but his own.” Id.

Accordingly, discoveries that possess “markedly different characteristics from any found in nature,” id., are eligible for patent protection. In contrast, any existing organism or newly discovered plant found in the wild is not patentable. Id. at 309, 100 S.Ct. 2204;see also In re Beineke, 690 F.3d 1344, 1352 (Fed.Cir.2012), cert. denied,––– U.S. ––––, 133 S.Ct. 1243, ...