Facts: The inventors filed a patent application directed to DNA and cDNA molecules that encoded heparin binding growth factor (HBGF). The examiner rejected the claims as obvious and the Board of Patent Appeals and Interferences affirmed. The examiner cited two prior art references. The Bohlen references provided a partial amino acid sequence of HBGF and did not address the DNA coding of the enzyme. The Maniatis reference disclosed the method of gene cloning that the applicants had used.

Issue: Whether the combination of a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, may render DNA and cDNA molecules encoding the protein prima facie obvious under 35 USC § 103.

Holding: No. In order to establish that a structurally novel chemical compound is prima facie obvious, the teachings of the prior art must suggest the claimed compounds to a PHOSITA (person having ordinary skill in the art).

Reasoning: Obviousness is normally based on structural similarity between the claimed and prior art compounds. Structural similarities may provide a motivation or suggestion to prepare new analogs of known compounds. Such similarities can include geometric or positional isomers or homologs.

In such cases, “the question becomes whether the prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention.” See In re Dillon. Only then does the burden shift to the inventor to rebut the prima facie case of obviousness.

The court held that the prior art did not disclose any relevant DNA molecules or close relatives of the claimed compounds. While the protein sequence was known, the redundancy of the genetic code provided too many alternatives for one to have contemplated or focus on the claimed compounds. One could not have conceived of the sequence until it was isolated and purified and what cannot be contemplated or conceived cannot be obvious. A motivation to search for a gene with a known property does not make the specific gene that is found obvious.

Brief Summary of Holding:

(1) Combination of prior art reference teaching method of gene cloning, together with reference disclosing partial amino acid sequence for a protein that stimulated cell division did not render claims prima facie obvious;

(2) Conceived method of preparing some unidentified DNA does not define it with precision necessary to render it obvious over protein it encodes; and

(3) Patent claims generically encompassing all DNA sequences encoding human and bovine proteins to stimulate cell division were not invalid as obvious.

Disposition: Reversed.

In re Thomas F. DEUEL, Yue-Sheng Li, Ned R. Siegel and Peter G. Milner.

In re Deuel, 51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995).

Tags: 35 USC 103, Biotech, case, Cases, DNA, law, obviousness, Patent

Facts:

Pioneer owned several patents directed to plants and seeds of new varieties of hybrid and inbred corn. When Pioneer sued J.E.M. for infringement, J.E.M. moved for summary judgment on the basis that sexually reproduced plants are not patentable subject matter under 35 U.S.C. § 101. Citing Diamond v. Chakrabarty, the district court denied J.E.M.’s motion and held that 35 U.S.C. § 101 covers plant life and that sexually reproducing plants are patentable subject matter. A unanimous panel of the Court of Appeals for the Federal Circuit affirmed the district court’s decision.

Issue:

Whether sexually reproduced plants and seeds are patentable subject matter within the scope of 35 U.S.C. § 101, despite being unpatentable under the later enacted and more specific Plant Variety Protection Act (PVPA).

Holding:

Yes. Plants are patentable subject matter under both the PVPA and 35 U.S.C. § 101.

Reasoning:

J.E.M. had argued that 35 USC § 101 did not apply to seeds and seed grown plants because Congress intended that they be protected under the Plant Protection Act of 1930 (PPA) and the (PVPA), and that the general statute was superseded by the more specific PVPA.

The Court held that Congress did not intend for the PVPA to exclude new plant varieties from protection under the patent statues. The court held that 35 USC and the PVPA differ in the rights and obligations imposed on a prospective patentee in order to obtain patent protection, but that plants are patentable subject matter under both.

Disposition: Affirmed.

J. E. M. Ag Supply, Inc., dba Farm Advantage, Inc., et al., Petitioners v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001).

Tags: Biotech, case, Cases, intellectual property, law, Patent, supreme court, utility

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Argued March 17, 1980. Decided June 16, 1980.

Facts:

Chakrabarty filed a patent application directed to an oil-eating bacterium. The PTO rejected a claim to the bacterium itself on the grounds that living matter is not patentable subject matter. The Board of Patent Appeals and Interferences upheld the examiner’s rejection. The rejection was overturned on appeal to the US Court of Customs and Patent Appeals and the US Supreme Court granted certiorari.

Issue: Are human-made micro-organisms patentable subject matter?

Holding:

Living organisms are patentable subject matter under 35 USC 101 and Chakrabarty’s micro-organism constitutes a “manufacture” or “composition of matter” within the meaning of that statute. The Court held that the terms “manufacture” and “composition of matter” are to be given a broad construction.

The court noted that the judiciary must be cautious when contemplating expanding patent law to new areas that Congress had not foreseen. The court noted however that title 35 contains no ambiguity and was to be construed broadly. The PTO also argued that the court should reject the patenting of living organisms as against public policy. The court held that such a determination was the province of the judiciary and held that the oil-eating bacterium was patentable subject matter.

Tags: Biotech, case, Cases, fpost, micro-organism, Patent, utility