Schendel v. Curtis

Decision Date14 May 1996
Docket NumberNo. 95-1329,95-1329
PartiesPaul SCHENDEL, Appellant, v. Benson M. CURTIS, Linda S. Park, and David J. Cosman, Appellees.
CourtU.S. Court of Appeals — Federal Circuit

Bruce M. Collins, Mathews, Woodbridge & Collins, Princeton, New Jersey, argued for appellant. With him on the brief was Scott N. Bernstein.

John P. Isacson, Jr., Foley & Lardner, Washington, D.C., argued for appellees. With him on the brief were Stephen A. Bent and Lawrence M. Sung.

Before NEWMAN, LOURIE, and BRYSON, Circuit Judges.

Opinion by the court filed by Circuit Judge LOURIE. Dissenting opinion filed by Circuit Judge NEWMAN.

LOURIE, Circuit Judge.

Paul Schendel appeals from the April 19, 1995 decision of the United States Patent and Trademark Office Board of Patent Appeals and Interferences ("board" or "PTO") granting summary judgment in favor of Benson M. Curtis, Linda S. Park, and David J. Cosman (collectively "Curtis") in Interference No. 103,443. Because the board did not err in granting summary judgment, we affirm.

BACKGROUND

This appeal concerns an interference between the parties Schendel and Curtis. Schendel, the junior party, is the applicant of U.S. Patent Application 08/057,198. 1 The application was assigned to Genetics Institute. Curtis is the senior party, Curtis, Park, and Cosman being the inventors of U.S. Patent 5,073,627, assigned to Immunex Corporation. 2

The invention at issue is a fusion protein, which is a molecule that contains the amino acid sequences of two different proteins. 3 Specifically, the invention is a fusion protein of interleukin-3 ("IL-3") and a hematopoietin, which may be granulocyte colony stimulating factor ("G-CSF") or granulocyte-macrophage colony stimulating factor ("GM-CSF"). The count of the interference requires that the fusion protein components be linked together either directly or through a peptide linker.

Schendel sought to provoke an interference with Curtis by presenting in his application claims corresponding substantially to the claims of the '627 patent. Schendel's effective Accordingly, Schendel stated that he was prima facie entitled to a judgment based on his actual reduction to practice of an IL-3/G-CSF fusion protein before Curtis's effective filing date. In support of his contention, he submitted six declarations describing acts that he and other Genetics Institute employees allegedly performed before Curtis's effective filing date. In particular, Schendel submitted the following declarations:

                filing date, however, was more than three months after Curtis's effective filing date.   Therefore, before the interference could be declared, the patent examiner required Schendel to submit evidence showing that he was "prima facie entitled to a judgment" relative to Curtis, together with "an explanation stating with particularity" why he was "prima facie entitled to the judgment."   See 37 C.F.R. § 1.608(b) (1994). 4
                

1. A declaration of Paul Schendel describing his alleged preparation of an IL-3/G-CSF fusion protein;

2. A declaration of Steven C. Clark stating that Schendel discussed with him Schendel's idea of preparing a molecule in which two lymphokines, IL-3 and another hematopoietin, would be linked to form a covalent dimer;

3. A declaration of Hemchand Sookdeo stating that he prepared two 10-base oligonucleotides for Schendel's use "in sequencing second generation lymphokines;"

4. A declaration of JoAnn Giannotti stating that she received from Schendel a sample identified by Schendel as an IL-3/G-CSF fusion protein; this sample exhibited G-CSF activity when she subjected it to a murine bone marrow assay;

5. A declaration of Agnes B. Ciarletta stating that she received from Schendel a sample labelled by Schendel as an IL-3/G-CSF dimer; this sample exhibited IL-3 activity when she subjected it to an M07e assay; and

6. A declaration of Frances Bennett stating that she received from Schendel samples identified by Schendel as IL-3/G-CSF fusion proteins; these samples exhibited G-CSF activity when she subjected them to 32D and DA2 assays.

The board accordingly declared the interference between Schendel and Curtis. 5 Concurrently with the Declaration of Interference, an Administrative Patent Judge ("APJ") ordered Schendel to show cause why judgment should not be entered against him. See 37 C.F.R. § 1.617(a) (1994). 6 In the In accordance with 37 C.F.R. § 1.617(g), the board then reviewed the case to determine whether summary judgment should be granted against Schendel. After considering Schendel's evidence and arguments, the board held that Schendel had not established an actual reduction to practice of a fusion protein within the scope of the count before Curtis's effective filing date. The board, like the APJ, found that there was inadequate corroboration of Schendel's statements to support his alleged actual reduction to practice. The board also found that the evidence did not establish that Schendel had made a fusion protein meeting all the limitations of the count. Therefore, the board held that Schendel was not prima facie entitled to a judgment of priority and entered a decision granting summary judgment against Schendel. See 37 C.F.R. § 1.617(g). One board member dissented, arguing that the majority had applied too high a burden of proof. This appeal followed.

"show cause" order, the APJ asserted that there was insufficient corroboration of Schendel's statements concerning his alleged reduction to practice of the invention. In addition, the APJ asserted that the evidence did not establish that Schendel had reduced to practice a fusion protein meeting every limitation of the count. Schendel responded that there was adequate corroboration to support the statements in his declaration and that the evidence showed an actual reduction to practice of an IL-3/G-CSF fusion protein meeting every limitation of the count.
DISCUSSION

The issue before us is whether the board erred in holding that Schendel was not prima facie entitled to a judgment of priority against Curtis based upon Schendel's submitted evidence and arguments, which alleged an actual reduction to practice of the invention before Curtis's effective filing date. We review de novo the board's legal conclusion concerning an alleged reduction to practice. See Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376, 231 USPQ 81, 87 (Fed.Cir.1986), cert. denied, 480 U.S. 947, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987). We review the board's underlying factual findings for clear error. Id.

To establish priority based upon an alleged actual reduction to practice, Schendel was required to prove, inter alia, that he prepared a fusion protein meeting every limitation of the count. See Newkirk v. Lulejian, 825 F.2d 1581, 1582, 3 USPQ2d 1793, 1794 (Fed.Cir.1987) ("[E]very limitation of the interference count must exist in the embodiment and be shown to have performed as intended."); Hahn v. Wong, 892 F.2d 1028, 1032, 13 USPQ2d 1313, 1317 (Fed.Cir.1989) ("To establish reduction to practice of a chemical composition, it is sufficient to prove 'that the inventor actually prepared the composition and knew it would work.' ") (quoting Mikus v. Wachtel, 542 F.2d 1157, 1159, 191 USPQ 571, 573 (CCPA 1976)).

Schendel's burden of making a prima facie showing of priority required him to prove so much of his case as to entitle him to an award of priority if Curtis were to rely only on his filing date and were not to rebut any of Schendel's case. See Hahn, 892 F.2d at 1032, 13 USPQ2d at 1317; Kistler v. Weber, 56 C.C.P.A. 1413, 412 F.2d 280, 285, 162 USPQ 214, 218 (1969). Count 1 requires, among other limitations, a "fusion protein" in which the specified components "are linked either directly or through a peptide linker." The board concluded that Schendel had not made a prima facie showing that he had actually prepared a fusion protein, i.e., a molecule containing the component proteins linked either directly or through a peptide linker. We agree with the board's conclusion.

Schendel did not provide direct evidence that he prepared a fusion protein having the Schendel's declaration asserts that the final plasmid was transformed into an E. coli cell line. The declaration cites a laboratory notebook page containing a graph and Schendel's statement in the notebook that "[a]ll cultures induced well." The declaration asserts, in conclusory fashion, that "[t]his indicates that [Schendel] detected protein being made by [the] plasmids." It does not explain, however, what the data in the graph mean or how Schendel could have known from the data that he had successfully made the claimed fusion protein. Curtis argues that the graph depicts optical density data that indicate only the rate and level of host bacterial growth, not the amount of protein produced or, most importantly, the identity of the resulting protein. Schendel provides no persuasive response to this argument.

                structure required by the count.   Schendel's declaration describes the process he purportedly used to prepare an IL-3/G-CSF fusion protein.   Specifically, Schendel's declaration states that he constructed a plasmid containing IL-3 and G-CSF genes joined together by a linker, and verified the junctions between those genes.   The Sookdeo declaration suggests that Schendel obtained primers to sequence the linker junctions between the IL-3 and G-CSF coding regions of the plasmid, and Schendel's laboratory notebook entries suggest that he may have constructed portions of that plasmid.   Significantly, however, Schendel's laboratory notebook does not show that the complete plasmid was actually constructed or that its structure was identified (such as by DNA sequencing).   In addition, Schendel's declaration does not allege that he or anyone else at Genetics Institute ever sequenced the coding region of the plasmid allegedly used to prepare the relevant fusion protein.   Most particularly, he provided no data
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