The case of Nichols Institute Diagnostics, Inc. v. Scantibodies Clinical Lab., Inc., (Fed. Cir. Sept. 20, 2006), just decided by the Federal Circuit, is a reminder that inventors must be cautious about their pre-filing publications.

Defendant appealed from a district court order denying its motion for partial summary judgment of invalidity of Plaintiff’s U.S. Patent No. 6,030,790. On appeal, the Federal Circuit reversed the order, holding that all of the asserted claims were inherently anticipated under 35 U.S.C. § 102.

The case involved a patent for compositions of antibodies that selectively bind to specific peptide sequences of hPTH.  The Court summarized the art as follows:

Human Parathyroid Hormone (“hPTH”) is a protein comprised of 84 amino acids that plays an important role in regulating calcium metabolism. Various fragments of hPTH may circulate in the bloodstream; however, to be biologically active, a fragment of hPTH must include the first two amino acids and must be at least 34 amino acids long. The amount of biologically active hPTH circulating in a patient’s bloodstream may be measured by creating antibodies that bind to specific amino acid sequences, also referred to as peptides, of hPTH and then incorporating those antibodies into a well-known immunoassay test.

On September 12, 1994, Dr. Marcus Magerlein and five of his colleagues published an abstract disclosing that they created antisera containing antibodies that bound predominantly to hPTH peptides having the first two amino acids and antibodies that bound to peptides of hPTH containing blocks of amino acid sequences through 37. It was not until after the publication date that the authors of the abstract realized that, to be biologically active, a fragment of hPTH must have both the first two amino acids and be at least 34 amino acids long. Thus, it was not until after the abstract was published that the authors recognized that their disclosure could be used to specifically detect biologically active hPTH fragments.

More than one year later, on September 22, 1995, Dr. Magerlein and his colleagues filed a patent application for compositions of antibodies that selectively bind to specific peptide sequences of hPTH. 

In an action for patent infringement, Defendant sought summary judgment that the patent claims were anticipated by the inventors’ published abstract. The district court denied Defendant’s summary judgment motion, and Defendant appealed.

The Federal Circuit reversed the district court, holding that the abstract inherently anticipated the patent because (1) the antiserum disclosed in the abstract contained the claimed antibody, and (2) it was well known how to isolate the claimed antibody from the other antibodies in the disclosed serum. 

The Court held that the claims were anticipated, even though the abstract did not expressly disclose the “selective” binding capability of the claimed antibody, because it “was undisputed that once the antibody is isolated from the sera, using well-known purification methods, the isolated antibody necessarily will exhibit the claimed ‘selective’ binding.”

Moreover, it was immaterial that the inventors did not know the significance of the claimed antibody until after the abstract was submitted. “‘[I]nherent anticipation does not require a person of ordinary skill in the art to recognize the inherent disclosure in the prior art at the time the prior art is created.’ SmithKline, 403 F.3d at 1343 (citations omitted) . . . .”