11 F.3d 1046 (Fed. Cir. 1993), 93-1073, In re Goodman

Docket Nº:93-1073.
Citation:11 F.3d 1046
Party Name:29 U.S.P.Q.2d 2010 In re Robert GOODMAN, Vic C. Knauf, Catherine M. Houch and Luca Comai.
Case Date:December 03, 1993
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1046

11 F.3d 1046 (Fed. Cir. 1993)

29 U.S.P.Q.2d 2010

In re Robert GOODMAN, Vic C. Knauf, Catherine M. Houch and Luca Comai.

No. 93-1073.

United States Court of Appeals, Federal Circuit

December 3, 1993

Page 1047

Lloyd R. Day, Jr., Cooley, Godward, Castro, Huddleson & Tatum, Palo Alto, CA, argued for appellant. With him on the brief were, Barbara Rae-Venter, PH.D. and Linda A. Sasaki. Of counsel was, Elizabeth Lassen, Calgene, Inc., Davis, CA.

Teddy S. Gron, Associate Sol., Office of the Sol., Arlington, VA, argued for appellee. With him on the brief were, Fred E. McKelvey, Sol. and Richard E. Schafer, Associate Sol. Of counsel were, Albin F. Drost and Lee E. Barrett, Office of the Sol.

Before RICH, RADER, and SCHALL, Circuit Judges.

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RADER, Circuit Judge.

Robert M. Goodman et al. (Goodman) appeal the rejection of claims 1-13 of application No. 07/507,380 (the '380 application). The Board of Patent Appeals and Interferences (Board) of the United States Patent and Trademark Office (PTO) rejected for lack of an enabling disclosure and for obviousness-type double patenting. This court affirms the Board.

BACKGROUND

The claims on appeal define a method of manufacturing mammalian peptides in plant cells. The method calls for integration into plant cells of a DNA construct encoding a mammalian peptide. This transferred DNA construct includes regulatory regions functional in the plant. The regulatory regions instruct the plant cell to transcribe the region of the DNA coding for the mammalian peptide. The method calls for harvesting the valuable peptide after translation of the transcribed messenger RNA.

The application claims an invention of broad scope--a method for producing mammalian peptides in plant cells. When the bacterium Agrobacterium tumefaciens infects a wound on a dicotyledonous plant, the bacterium attaches to the plant cell wall and introduces a particular piece of its Ti plasmid 1 DNA into the plant cell. This piece of plasmid is the T-DNA (Transferred DNA). The T-DNA integrates into the nuclear genome of the plant cell. The plant cell then manufactures certain enzymes, encoded according to the T-DNA segment, for synthesis of tumor-specific compounds called opines.

Accordingly, upon insertion of a foreign DNA segment into the T-region of the Ti plasmid, the natural genetic transfer functions of these bacteria introduce the foreign segment into the plant cell genome. Using its own cell machinery, the plant cell then dutifully strives to transcribe the T-DNA segment and translate the peptide it encodes. Numerous factors affect successful transcription and translation, including the regulatory gene regions (i.e., initiation and termination sequences) preceding and following the T-DNA segment as well as intracellular compounds present during protein formation. If a stable translation product results, the peptide can be harvested from the plant cells.

Independent claim 1 provides:

1. A method for producing a mammalian peptide which comprises:

growing plant cells containing an integrated sequence comprising,

a first expression cassette having in the direction of transcription (1) a transcriptional and translational initiation region functional in said plants cells, (2) a structural gene coding for said mammalian peptide, and (3) a termination region,

whereby said structural gene is expressed to produce said mammalian peptide; and

isolating said mammalian peptide substantially free of plant cell components.

Claims 1-6 specify methods for producing mammalian peptides in plant cells using expression cassettes 2 with initiation codons recognized by plant cells. Claims 7-9 are directed to production of the peptide interferon in plant cells. Claims 10-13 specify nucleic acid constructs for use in the method claims.

The '380 application is a continuation of 06/760,236, which issued as U.S. Patent No. 4,956,282 (the '282 patent). The '282 patent claims a method for producing an interferon in dicotyledonous plant cells. Claim 1 of the '282 patent is identical to claim 8 of the '380 application except that application claim 8 specifies only "plant cells," rather than dicotyledonous plant cells. The '380 application thus has claims broader than those of the issued patent. Stated otherwise,

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the claims of the '282 patent are species of the genus claimed in the '380 application.

Application claim 9 is similarly identical to claim 2 of the '282 patent with the exception of the dicotyledonous limitation. Application claim 13 is identical to claim 3 of the '282 patent except that the '282 patent is limited to gamma-interferon rather than "an interferon." Accordingly, these claims also present genus-species relationships between the '380 application and the '282 patent.

The specifications of the '282 patent and the '380 application describe the claimed method in general terms, but provide only a single working example. The example describes the formation of an expression cassette with regulatory regions functional in tobacco plants and a structural gene coding for gamma-interferon. In the example the expression cassette is joined to a selectable marker to simplify isolation of plant cells that successfully integrate the construct. The selectable marker consists of regulatory regions functional in tobacco plants and a DNA sequence coding for a tetracycline resistance gene.

Claims 1-6 on appeal, however, purport to cover any desired mammalian peptide produced in any plant cell. Dependent claims 2-6 add limitations--such as specifying the use of a marker, Ti plasmids, and T-DNA boundary regions--but in no way limit the type of mammalian peptide produced or the type of plant cell used.

Independent claim 7, claim 8 dependent therefrom, and claim 9 dependent from claim 8, specify an interferon as the mammalian protein produced by the method. None of the claims, however, limit the type of plant cell in the method.

Claim 10 claims a DNA construct with regulatory regions functional in plant cells and a structural gene coding for an interferon. Claim 11, dependent therefrom, adds the limitation of a second sequence which is a selectable marker. Claim 12, further dependent from claim 11, requires the second sequence to include a T-DNA boundary. Independent claim 13 specifies a DNA construct for producing an interferon in plant cells and containing an antibiotic resistance selectable marker.

The Board's Rejection

The Board affirmed the Examiner's rejection of claims 1-9 under 35 U.S.C. Sec. 112, first paragraph. According to the Board, the specification did not enable one of ordinary skill in the art to produce any mammalian peptide with the claimed method on July 29, 1985, the effective filing date of the application. Regarding enablement, the Board stated:

[E]ven if one were to read into the claim recitation a limitation that the regulatory region was native either to the plant cell in question or the mammalian cell in question, the present specification would still lack adequate guidance to enable one of ordinary skill to extend [Goodman's] invention beyond the single working example.

According to the Board, Goodman's specification did not disclose the "plant functional" regulatory regions for plants beyond the single example. Thus, one of skill in the art could not replicate the invention in "all plants." Furthermore, the Board found that the specification taught only the Agrobacterium -mediated transformation method of plant transformation. This method works only with dicotyledonous plant cells, not all "plant cells."

The Board also affirmed the rejection of claims 1-13 under the doctrine of obviousness-type double patenting in light of claims 1-3 of the '282 patent. The Board held that the issuance of the present claims in the absence of a terminal disclaimer would grant an "unjustified timewise extension of right to exclude granted by a patent." In re Schneller, 397 F.2d 350, 354, 158 USPQ 210, 214 (CCPA 1968) (emphasis added). The Board found that the conflicting claims are not patentably distinct from each other because both claim methods and expression cassettes for producing mammalian peptides in plant cells.

DISCUSSION

Whether Goodman's specification satisfies 35 U.S.C. Sec. 112's enablement requirement

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is a question of law which this court reviews independently. In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed.Cir.1991); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed.Cir.), cert. denied, --- U.S. ----, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991). This court reviews the factual findings underlying that conclusion of law for clear error. Vaeck, 947 F.2d at 495. Similarly, a rejection under the doctrine of obviousness-type double patenting is a legal conclusion this court reviews freely. See In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed.Cir.1986).

Enablement

The first paragraph of 35 U.S.C. Sec. 112 provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains ... to make and use the same....

The specification, when filed, must enable one skilled in the particular art to use the invention without undue experimentation. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988). Naturally, the specification must teach those of skill in the art "how to make and how to use the invention as broadly as it is claimed." Vaeck, 947 F.2d at 496.

Goodman's specification contains a single example of producing gamma-interferon in the dicotyledonous species, tobacco. This single example, however, does not enable a biotechnician of ordinary skill to produce any type of mammalian protein in any type of plant cell. The specification does not contain sufficient information to enable the broad...

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