421 F.3d 1365 (Fed. Cir. 2005), 04-1465, In re Fisher

Docket Nº:04-1465.
Citation:421 F.3d 1365
Party Name:76 U.S.P.Q.2d 1225 In re Dane K. FISHER and Raghunath V. Lalgudi.
Case Date:September 07, 2005
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

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421 F.3d 1365 (Fed. Cir. 2005)

76 U.S.P.Q.2d 1225

In re Dane K. FISHER and Raghunath V. Lalgudi.

No. 04-1465.

United States Court of Appeals, Federal Circuit.

Sept. 7, 2005

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Seth P. Waxman, Wilmer Cutler Pickering Hale and Dorr LLP, of Washington, DC, argued for appellants. With him on the brief were William F. Lee and Richard W. O'Neill, of Boston, Massachusetts; and William G. McElwain and Henry N. Wixon, of Washington, DC.

Stephen Walsh, Associate Solicitor, United States Patent and Trademark Office, of Arlington, Virginia, argued for the Director of the Patent and Trademark Office. With him on the brief were John M. Whealan, Solicitor, and Thomas W. Krause, Associate Solicitor.

Joseph A. Keyes, Jr., of Washington, DC, for amicus curiae Association of American Medical Colleges.

Marc S. Gold, of Washington, DC, for amicus curiae National Academy of Sciences.

Donald R. Stuart, of Indianapolis, Indiana, for amicus curiae Dow AgroSciences LLC. With him on the brief was Kenneth B. Ludwig.

Paula K. Davis, of Indianapolis, Indiana, for amicus curiae Eli Lilly and Company. With her on the brief were Steven P. Caltrider and James J. Kelley.

Michael C. Schiffer, of Irvine, California, for amicus curiae Baxter Healthcare Corporation.

Darrel C. Karl, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, for amicus curiae American College of Medical Genetics.

Jeffrey P. Kushan, Sidley Austin Brown & Wood, LLP, of Washington, DC, for amicus curiae Genentech, Inc. With him on the brief were Kathi A. Cover and David L. Fitzgerald.

George C. Yu, of Emeryville, California, for amicus curiae Affymetrix, Inc.

Dissenting opinion filed by Circuit Judge RADER.

Before MICHEL, Chief Judge, RADER and BRYSON, Circuit Judges.


MICHEL, Chief Judge.

Dane K. Fisher and Raghunath Lalgudi (collectively "Fisher") 1 appeal from the decision of the U.S. Patent and Trademark Office ("PTO") Board of Patent Appeals and Interferences ("Board") affirming the examiner's final rejection of the only pending claim of application Serial No. 09/619,643

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(the " '643 application"), entitled "Nucleic Acid Molecules and Other Molecules Associated with Plants," as unpatentable for lack of utility under 35 U.S.C. § 101 and lack of enablement under 35 U.S.C. § 112, first paragraph. Ex parte Fisher, App. No.2002-2046 (Bd.Pat.App.Int. Mar. 16, 2004) (" Board Decision "). This appeal was submitted after oral argument on May 3, 2005. Because we conclude that substantial evidence supports the Board's findings that the claimed invention lacks a specific and substantial utility and that the '643 application does not enable one of ordinary skill in the art to use the invention, we affirm.


A. Molecular Genetics and ESTs

The claimed invention relates to five purified nucleic acid sequences that encode proteins and protein fragments in maize plants. The claimed sequences are commonly referred to as "expressed sequence tags" or "ESTs." Before delving into the specifics of this case, it is important to understand more about the basic principles of molecular genetics and the role of ESTs.

Genes are located on chromosomes in the nucleus of a cell and are made of deoxyribonucleic acid ("DNA"). DNA is composed of two strands of nucleotides in double helix formation. The nucleotides contain one of four bases, adenine ("A"), guanine ("G"), cytosine ("C"), and thymine ("T"), that are linked by hydrogen bonds to form complementary base pairs (i.e., A-T and G-C).

When a gene is expressed in a cell, the relevant double-stranded DNA sequence is transcribed into a single strand of messenger ribonucleic acid ("mRNA"). Messenger RNA contains three of the same bases as DNA (A, G, and C), but contains uracil ("U") instead of thymine. mRNA is released from the nucleus of a cell and used by ribosomes found in the cytoplasm to produce proteins.

Complementary DNA ("cDNA") is produced synthetically by reverse transcribing mRNA. cDNA, like naturally occurring DNA, is composed of nucleotides containing the four nitrogenous bases, A, T, G, and C. Scientists routinely compile cDNA into libraries to study the kinds of genes expressed in a certain tissue at a particular point in time. One of the goals of this research is to learn what genes and downstream proteins are expressed in a cell so as to regulate gene expression and control protein synthesis. 2

An EST is a short nucleotide sequence that represents a fragment of a cDNA clone. It is typically generated by isolating a cDNA clone and sequencing a small number of nucleotides located at the end of one of the two cDNA strands. When an EST is introduced into a sample containing a mixture of DNA, the EST may hybridize with a portion of DNA. Such binding shows that the gene corresponding to the EST was being expressed at the time of mRNA extraction.

Claim 1 of the '643 application recites:

A substantially purified nucleic acid molecule that encodes a maize protein or fragment thereof comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO: 1 through SEQ ID NO: 5.

The ESTs set forth in SEQ ID NO: 1 through SEQ ID NO: 5 are obtained from cDNA library LIB3115, which was generated from pooled leaf tissue harvested

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from maize plants (RX601, Asgrow Seed Company, Des Moines, Iowa, U.S.A.) grown in the fields at Asgrow research stations. SEQ ID NO:1 through SEQ ID NO:5 consist of 429, 423, 365, 411, and 331 nucleotides, respectively. When Fisher filed the '643 application, he claimed ESTs corresponding to genes expressed from the maize pooled leaf tissue at the time of anthesis. Nevertheless, Fisher did not know the precise structure or function of either the genes or the proteins encoded for by those genes.

The '643 application generally discloses that the five claimed ESTs may be used in a variety of ways, including: (1) serving as a molecular marker for mapping the entire maize genome, which consists of ten chromosomes that collectively encompass roughly 50,000 genes; (2) measuring the level of mRNA in a tissue sample via microarray technology to provide information about gene expression; (3) providing a source for primers for use in the polymerase chain reaction ("PCR") process to enable rapid and inexpensive duplication of specific genes; (4) identifying the presence or absence of a polymorphism; (5) isolating promoters via chromosome walking; (6) controlling protein expression; and (7) locating genetic molecules of other plants and organisms.

B. Final Rejection

In a final rejection, dated September 6, 2001, the examiner rejected claim 1 for lack of utility under § 101. The examiner found that the claimed ESTs were not supported by a specific and substantial utility. She concluded that the disclosed uses were not specific to the claimed ESTs, but instead were generally applicable to any EST. For example, the examiner noted that any EST may serve as a molecular tag to isolate genetic regions. She also concluded that the claimed ESTs lacked a substantial utility because there was no known use for the proteins produced as final products resulting from processes involving the claimed ESTs. The examiner stated: "Utilities that require or constitute carrying out further research to identify or reasonably confirm a 'real world' context of use are not substantial utilities."

The examiner also rejected the claimed application for lack of enablement under § 112, first paragraph. She reasoned that one skilled in the art would not know how to use the claimed ESTs because the '643 application did not disclose a specific and substantial utility for them.

On July 19, 2000, Fisher filed a notice of appeal with the Board.

C. Board Proceedings

The Board considered each of Fisher's seven potential uses but noted that Fisher focused its appeal on only two: (1) use for the identification of polymorphisms; and (2) use as probes or as a source for primers. As to the first, the Board found that the application failed to explain why the claimed ESTs would be useful in detecting polymorphisms in maize plants. Board Decision, slip op. at 14. The Board reasoned that "[w]ithout knowing any further information in regard to the gene represented by an EST, as here, detection of the presence or absence of a polymorphism provides the barest information in regard to genetic heritage." Id., slip op. at 15. Thus, the Board concluded that Fisher's asserted uses for the claimed ESTs tended to the "insubstantial use" end of the spectrum between a substantial and an insubstantial utility. Id.

The Board also concluded that using the claimed ESTs to isolate nucleic acid molecules of other plants and organisms, which themselves had no known utility, is not a substantial utility. Id., slip op. at 16. Specifically, the Board noted that Fisher argued that the "claimed ESTs may be

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useful in searching for promoters that are only active in leaves at the time of anthesis." Id. The Board found, however, that the application failed to show that the claimed ESTs would be expressed only during anthesis or that they would be capable of isolating a promoter active in maize leaves at the time of anthesis. Id., slip op. at 18.

Additionally, the Board addressed the remaining asserted utilities, highlighting in particular the use of the claimed ESTs to monitor gene expression by measuring the level of mRNA through microarray technology and to serve as molecular markers. The Board found that using the claimed ESTs in screens does not provide a specific benefit because the application fails to provide any teaching regarding how to use the data relating to gene expression. Id., slip op. at...

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