In Re Kubin
2009 U.S. App. LEXIS 6914, 90 U.S.P.Q. 2d (BNA) 1417, 561 F.3d 1351 (2009)
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Rule of Law:
When the prior art discloses a protein of interest, a motivation to isolate its encoding gene, and conventional, detailed methodologies (including specific probes) for doing so with a reasonable expectation of success, the resulting isolated gene sequence is unpatentably obvious under 35 U.S.C. § 103(a), even if the specific sequence was not explicitly disclosed in the prior art.
Facts:
- Marek Kubin and Raymond Goodwin filed a patent application claiming DNA molecules (polynucleotides) encoding a protein known as Natural Killer Cell Activation Inducing Ligand (NAIL).
- NAIL is a specific receptor protein on the surface of Natural Killer (NK) cells that plays a role in activating these cytotoxic lymphocytes.
- The claimed invention specifically describes a genus of isolated polynucleotides encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.
- U.S. Patent No. 5,688,690 (Valiante) disclosed a receptor protein called 'p38' found on human NK cells, which is the same protein as NAIL, and taught that p38 can serve as an activation marker for cytotoxic NK cells.
- Valiante also disclosed and claimed a monoclonal antibody (mAB C1.7) specific for p38 and taught that the DNA and protein sequences for p38 could be obtained by conventional methodologies known to one of skill in the art, citing Sambrook et al. for detailed methods.
- Valiante described a five-step cloning protocol for 'isolating and identifying the p38 receptor' using mAB C1.7 to screen a human NK cell library.
- Porunelloor Mathew et al. (Mathew) disclosed a cell surface receptor protein called 2B4, involved in activating mouse NK cells, and taught a detailed cloning protocol for obtaining its gene, noting that 2B4 was later discovered to be the murine equivalent of Valiante’s p38.
- Kubin and Goodwin used conventional techniques, such as those outlined in Sambrook, and the commercial monoclonal antibody C1.7 (disclosed by Valiante) to isolate and sequence the gene that codes for NAIL.
Procedural Posture:
- Marek Kubin and Raymond Goodwin filed U.S. Patent Application Serial No. 09/667,859.
- The Board of Patent Appeals and Interferences (BPAI) rejected the claims of the ’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.
- Kubin and Goodwin appealed the Board's decision to the United States Court of Appeals for the Federal Circuit.
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Issue:
Is a genus of isolated nucleic acid molecules encoding a known protein unpatentably obvious under 35 U.S.C. § 103(a) when the prior art discloses the protein, a motivation to isolate its gene, a specific monoclonal antibody for the protein, and conventional, detailed methods for isolating its gene with a reasonable expectation of success?
Opinions:
Majority - Rader
Yes, a genus of isolated nucleic acid molecules encoding a known protein is unpatentably obvious when the prior art discloses the protein, a motivation to isolate its gene, a specific monoclonal antibody for the protein, and conventional, detailed methods for isolating its gene with a reasonable expectation of success. The court affirmed the Board's conclusion that Kubin and Goodwin’s claims were obvious under 35 U.S.C. § 103(a). The Board had substantial evidence to find that appellants used conventional techniques, as taught in Valiante and Sambrook, to isolate the NAIL gene. Valiante disclosed the p38 protein (identical to NAIL), a specific monoclonal antibody (mAb C1.7) for it, and detailed methods, including a five-step protocol and reference to Sambrook, for cloning its gene. The court referenced the Supreme Court's decision in KSR International Co. v. Teleflex Inc., which clarified the “obvious to try” doctrine. KSR discredited the strict interpretation found in cases like In re Deuel, establishing that if there is a design need or market pressure to solve a problem, and a finite number of identified, predictable solutions, pursuing known options with an anticipated success is a product of ordinary skill, not innovation. The present case fit this KSR framework: Valiante provided a protein of interest and methods to isolate its gene, with a clear motivation to do so due to NAIL's important role in the immune response. A skilled artisan would have had a “reasonable expectation of success” in deriving the claimed invention, which is all that is required for obviousness. The court rejected arguments to limit KSR to “predictable arts,” noting that biotechnology methods like cloning and sequencing are often well-known and reliable, making the result predictable. The court also held that even if no prior art explicitly discussed NAIL's binding to CD48, the application itself described CD48 binding as an inherent property of NAIL, so obtaining NAIL cDNA necessarily yielded this property.
Analysis:
This case is a landmark decision that significantly impacted patentability in the biotechnology field by applying the Supreme Court's KSR obviousness standard to gene sequences. It effectively limited the strict precedential value of In re Deuel, which had previously made it difficult to find gene sequences obvious when only the protein and cloning methods were known. The decision clarifies that if a protein, a motivation to clone its gene, and conventional, reliable cloning methods are known, the resulting gene sequence is likely obvious, particularly when there is a 'reasonable expectation of success.' This ruling encourages more genuine innovation beyond merely identifying and sequencing natural products using established techniques, aligning biotechnology patent law more closely with other scientific fields.
