Federal Circuit Denies Kubin's DNA Patent Application for Being Obvious

Holding:

In a case that has far-reaching consequences on patenting of biotechnology, the U.S. Court of Appeals for the Federal Circuit affirmed the rejection of claims of U.S. Patent Application Serial No. 09/667,859 (“’859 Application”) as obvious under 35 U.S.C. § 103(a). This case presented a claim to a classic biotechnology invention – the isolation and sequencing of a human gene that encodes a particular domain of a protein. Specifically, appellants Marek Kubin and Raymond Goodwin claimed DNA molecules (“polynucleotides”) encoding a protein (“polypeptide”) known as the Natural Killer Cell Activation Inducing Ligand (“NAIL”) According to the Federal Circuit, court record showed that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Citing court precedent, the Federal Circuit stated that a skilled artisan would have had a resoundingly “reasonable expectation of success” in deriving the claimed invention in light of the teachings of the prior art. Further, the Federal Circuit declined to confine KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) to the “predictable arts” (as opposed to the “unpredictable art” of biotechnology). In fact, the Federal Circuit explained, the record showed that one of skill in this advanced art would find these claimed “results” profoundly “predictable.” On this basis, the Federal Circuit concluded that the Board of Patent Appeals and Interferences (“BPAI”) did not err in in finding that appellants’ claims obvious as a matter of law.

Detailed Summary:

Appellants appealed from a decision of the BPAI rejecting the claims of U.S. Patent Application Serial No. 09/667,859 (“’859 Application”) as obvious under 35 U.S.C. § 103(a) and invalid under 35 U.S.C. § 112 ¶ 1 for lack of written description. opinion, p. 1, citing Ex parte Kubin, No. 2007-0819 (B.P.A.I. May 31, 2007) (“Board Decision”).

This case presents a claim to a classic biotechnology invention – the isolation and sequencing of a human gene that encodes a particular domain of a protein. Specifically, appellants claim DNA molecules (“polynucleotides”) encoding a protein (“polypeptide”) known as the Natural Killer Cell Activation Inducing Ligand (“NAIL”).

BPAI rejected appellants’ claims as invalid under both § 103 and § 112. With regard to the § 112 rejection, the Board found the genus of nucleic acids of representative claim 73 unsupported by an adequate written description.

Regarding obviousness, BPAI rejected appellants’ claims over the combined teachings of U.S. Patent No. 5,688,690 (“Valiante”) and 2 Joseph Sambrook et al., Molecular Cloning: A Laboratory Manual 43-84 (2d ed. 1989) (“Sambrook”). BPAI also considered, but found to be cumulative to Valiante and Sambrook, Porunelloor Mathew et al., Cloning and Characterization of the 2B4 Gene Encoding a Molecule Associated with Non-MHC-Restricted Killing Mediated by Activated Natural Killer Cells and T Cells, 151 J. Immunology 5328-37 (1993) (“Mathew”).

In this appeal, the Federal Circuit affirmed the BPAI’s obviousness finding.  Specifically, the Federal Circuit found that substantial evidence supported the BPAI’s factual finding that “(a)ppellants employed conventional methods, ‘such as those outlined in Sambrook,’ to isolate a cDNA encoding NAIL and determine the cDNA’s full nucleotide sequence (SEQ NOS: 1 & 3).” Id., p. 9, citing Board Decision at 5. Further, substantial evidence supported the BPAI’s conclusion that Matthew reinforces the relative ease of deriving the claimed sequence following the teachings of the prior art.

The record showed, the Federal Circuit added,  that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is “the product not of innovation but of ordinary skill and common sense.” Id., p. 16, citing KSR, 550 U.S. at 421.

Stated in another way, the record showed that a skilled artisan would have had a resoundingly “reasonable expectation of success” in deriving the claimed invention in light of the teachings of the prior art. Id., citing In re O’Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988).

In affirming the BPAI’s holding, the Federal Circuit held that the prior art here provides a “reasonable expectation of success” for obtaining a polynucleotide within the scope of claim 73, , which, “(f)or obviousness under § 103 (is) all that is required.” Id., p. 18, citing Board Decision at 6, and O’Farrell, 853 F.2d at 903.

The instant case also gave the Federal Circuit the occasion to consider the BPAI’s application of its early assessment of obviousness in the context of classical biotechnological inventions, specifically In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995). In Deuel, the Federal Circuit reversed the BPAI’s conclusion that a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, rendered DNA molecules encoding the protein obvious. Id., p. 12, citing Deuel at 1559. Further, the Federal Circuit stated that “obvious to try” is an inappropriate test for obviousness.

The Federal Circuit wrote: “Insofar as Deuel implies the obviousness inquiry cannot consider that the combination of the claim’s constituent elements was ‘obvious to try,’ the Supreme Court in KSR unambiguously discredited that holding. In fact, the Supreme Court expressly invoked Deuel as a source of the discredited ‘obvious to try’ doctrine. The KSR Court reviewed this court’s rejection, based on Deuel, of evidence showing that a particular combination of prior art elements was obvious because it would have been obvious to one of ordinary skill in the art to attempt such a combination….The Supreme Court repudiated as ‘error’ the Deuel restriction on the ability of a skilled artisan to combine elements within the scope of the prior art.”

On the basis of the foregoing, the Federal Circuit concluded that the BPAI did not err appellants’ claims obvious.  Further, it stated that it need not address appellants’ contention that the BPAI erred in finding its claims invalid under Section 112(1).

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