Federal Circuit Affirms Obviousness of Gene Sequencing Claim As “Obvious To Try.”

In In re Kubin, 561 F.3d 1351 (Fed. Circ. 2009), the applicants filed Patent Application Serial No. 09/667,859 drawn to gene sequencing claims.  The applicants applied for a patent claiming DNA molecules (“polynucleotides”) that encoded a protein (“polypeptide”) known as the Natural Killer Cell Activation Inducing Ligand (“NAIL”).  Natural Killer (“NK”) cells play a major role in fighting tumors and viruses, and express surface molecules that can activate cytotoxic mechanisms when activated.  NAIL is a specific receptor protein on the cell surface that is involved in activating NK cells.  Applicants claimed the DNA that encodes the CD48-binding region of NAIL proteins.  Applicants’ claim 73 described a genus of isolated polynucleotides that encode a protein that binds CD48 and is at least 80% identical to the amino acid sequence that Applicants have disclosed in their specification.  In their specification, Applicants disclosed generic examples of variants of the amino acid sequence that could be contemplated under their claimed invention as at least 80% identical to the disclosed sequence.  However, the applicants did not set forth any specific examples of sequences of any such variants.

The Board upheld a rejection of applicants’ claimed invention under 35 U.S.C. § 112, 1st paragraph for lack of written description and a rejection under 35 U.S.C. § 103(a) for obviousness.  With respect to the lack of written description, the Board asserted that applicants had not described what domains of their described amino acid sequences were associated with the required binding to CD48, and thus did not describe which of NAIL’s amino acids could be varied and still bind.  The Board held that, without correlating the structure of the sequence with function, the specification did not provide adequate written description for claim 73.

The Board also affirmed that claim 73 was obvious under 35 U.S.C. § 103(a), under 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”).  The Board found (and Applicants did not dispute) the receptor protein p38 of Valiante to be the same protein as NAIL, existing on the surface of the NK cell and able to activate cytotoxicity.  Valiante taught that the DNA and protein sequences for p38 could be obtained by conventional methods (such as those set forth in Sambrook).  The Board held that the disclosure of p38, along with a detailed method of isolating its DNA, including disclosure of a specific probe to do so, established Valiante’s possession of p38’s amino acid sequence and provided a reasonable expectation of success in obtaining a polynucleotide encoding p38, within the scope of applicants’ claim 73. Further, the Board asserted that, given the importance of NAIL’s role in human immune response, motivation existed to apply conventional methodologies (like those of Sambrook) to isolate the NAIL cDNA.

On appeal, the Federal Circuit sustained the Board’s factual inquiries underlying the 35 U.S.C. § 103(a) rejection.  Specifically, the Applicants argued that there is insubstantial evidence to find that their methodology of isolating NAIL is equivalent to the teachings and methodologies of Valiante and Sambrook.  However, the Federal Circuit asserted that the claimed invention is not to the processes used, but rather to the results of those processes.  The Court held that the record was sufficient to show that Valiante’s examples would produce the claimed nucleotide.

Further, the Federal Circuit found that substantial evidence existed that the Applicants used conventional techniques as taught by Valiante and Sambrook to isolate the gene sequence for NAIL.  The Court rejected the Applicants’ argument that Valiante and Sambrook fail to provide guidance for preparing the cell culture to serve as a useful source of mRNA for the preparation of a cDNA library due to Applicants’ own admissions.  Specifically, the argument was rejected because Applicants asserted that the nucleic acid molecule had been derived from DNA or RNA isolated in pure form and in a quantity or concentration that enabled identification, manipulation and recovery of its component nucleotide sequences using standard biochemical methods (such as those provided by Sambrook). 

The Federal Circuit further held that prior art showing NAIL’s binding to the CD48 protein was not necessary to assert a finding of obviousness because CD48 binding is a property necessarily present in NAIL.  The Federal Circuit noted that discovering new qualities in a product that others had discovered or new functionality in a structure suggested by prior art is not an invention.  In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979); Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326US 242, 249 (1945).  Since the Board found that Valiante’s p38 was the same protein as applicants’ NAIL protein, Valiante’s teaching to obtain the cDNA encoding of p38 necessarily teaches one to obtain the cDNA of NAIL.  P38’s cDNA would necessarily exhibit the CD48 binding property and would fall under the scope of claim 73.

The Federal Circuit next rejected the idea that the “obvious to try” test should only be applied to predictable arts (as opposed to a more unpredictable arena like biotechnology).  The Federal Circuit held that patent law does not customize its tests for specific scientific fields.   In so doing, the Federal Circuit noted that its prior decision in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), which held that obvious to try was inappropriate as an obviousness rationale in the biotechnological arts, was suspect and greatly limited or overruled after the Supreme Court’s decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).  Rather, the Supreme Court held in KSR that where there is an identified need or pressure, and a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue known options within his or her technical grasp.  Solutions of this kind would not be the product of innovation, but rather one of ordinary skill and common sense.  Thus, the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. § 103.

After rejecting the analysis in In re Deuel, the Federal Circuit noted that the Supreme Court “actually resurrects this court’s own wisdom in In re O’Farrell [853 F.2d 894, 903 (Fed. Cir. 1988)].“  In re O’Farrell, which predated In re Deuel, noted that obvious to try was a rationale supporting an obviousness rejection.  However, the Federal Circuit also noted that the court in In re O’Farrell “cautioned that ‘obvious to try’ is an incantation whose meaning is often misunderstood.”  In order to differentiate between obviousness resulting from obvious to try and impermissible hindsight, the court in In re O’Farrell outlined situations (paralleled in KSR) in which passing the “obvious to try” test would be erroneously equated with obviousness. 

The first class of cases to which “obvious to try” should not be applied were those where the prior art gave no indication which parameters to vary or which choices were likely to be successful.  The second class of cases consisted of those exploring new technologies or a general approach where only general guidance existed as to the particular form of the invention or how to achieve it.  However, in contrast to these two cases, an obviousness finding under an “obvious to try” test would be appropriate when the prior art “contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” 853 F.2d at 902 (emphasis added).  The prior art did not have to require absolute predictability of success, but merely a reasonable expectation of such.

The Federal Circuit held that the Applicants’ case was dissimilar to either of the erroneous “obvious to try” classes.  With regards to claim 73, Valiante and Sambrook, which together teach a protein identical to NAIL, a commercially available monoclonal antibody specifically for NAIL, and explicit instructions for obtaining the DNA sequence for NAIL, gave more than general guidance as to how to achieve the specific form of the invention and provide clear direction as to which methods are likely to be successful.  Further, the prior art provided a reasonable expectation of successfully obtaining a polynucleotide of claim 73.  Thus, the Federal Circuit held that the “obvious to try” test should be applicable in this case.  Further, the Court asserted that use of the test shows that claim 73 was obvious and thus not patentable.

The Federal Circuit affirmed the Board’s ruling that applicants’ claims were obvious as a matter of law under the “obvious to try” test.  The prior art provided an identical protein to that claimed by applicants, a commercially available monoclonal antibody for that protein, and explicit instructions for obtaining the DNA for that protein.  Thus, the “obvious to try” test was appropriate because the prior art provided clear direction as to which methods were likely to be successful to achieve the invention, and a reasonable expectation of successfully obtaining a polynucleotide under claim 73.

Significance to Patent Applicants

In re Kubin removed a bright line distinction in how to apply obviousness analysis in predictable arts as opposed to those deemed unpredictable.  As such, merely by labeling a technology such as biotechnology unpredictable will no longer immunize applicants from the full scope of analysis authorized by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) and Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966). 

That being said, In re Kubin also reinforces the requirement that rejections based upon a conclusion that something is “obvious to try” must still be substantiated by evidence.  The Federal Circuit in In re Kubin heavily relied upon the existence of a manual as evidence of routine processing, and that the claimed result was merely the routine processing of a known protein.  Without such evidence, “obvious to try” is merely a conclusory statement.  Therefore, even after KSR, applicants should require that examiners provide evidence as to why a particular result would have been obvious to try.

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