In its Final Written Decision, the Board found that claims 94-97, 99, 110, and 111 of the ’915 Patent are unpatentable, granted Patent Owner’s unopposed Motion to Amend canceling claim 37 and claims 40, 47, 66, 67, 73, 76, 78-81, 83, 84, 86-89, 91, and 92 to the extent they depend from claim 37, dismissed Patent Owner’s Motion to Exclude Evidence as moot, and denied Petitioner’s Motion to Exclude Evidence.
The ’915 Patent relates to dietary folate supplementation. Specifically, the ’915 Patent proposes the use of natural isomers of reduced folates in dietary vitamin preparations. All of the claims that were considered on the merits require that one or more natural isomers of reduced folate administered be “substantially chirally pure 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof.”
The Board began with claim construction, stating that claim terms are interpreted according to their broadest reasonable construction in light of the specification. The Board repeated its construction for the term “substantially chirally pure,” which was not contested by the parties, and determined that no other claim terms require express construction beyond their ordinary and customary meanings.
The Board then turned to the argument that claims 94-97, 99, 100, and 111 are obvious over Serfontein and Marazza. The Board began its analysis by stating that it must undertake four factual inquiries: determining the scope and content of the prior art; ascertaining the differences between the prior art and claims at issue; resolving the level of ordinary skill in the pertinent art; and assessing objective evidence of nonobviousness. The Board first discussed the level of skill in the art. Because neither party addressed the level of skill in the pertinent art with evidence and neither party disputed that one of ordinary skill would have had knowledge of Serfontein and Marazza, the Board did not resolve the level of skill further.
The Board then reviewed the scope of the two prior art references and Patent Owner’s arguments. Patent Owner’s first argument was that because folic acid was regarded as the gold standard for folate supplementation in food and vitamins, one of ordinary skill would not have looked to other forms of folate. The Board was not persuaded by this argument because it does not follow that a person of ordinary skill would have avoided alternatives simply because a standard is known to be suitable and to work well. Patent Owner then argued that the prior art discouraged use of 5-methyl-(6S)-THFA to treat deficiency, but the Board found this unpersuasive because the evidence did not support the argument. Specifically, the Goodman & Gilman pharmacology textbook relied upon by Patent Owner states that folinic acid is not indicated for treating folate deficiency, but the Board found that this did not mean that folinic acid is not suitable for treating folate deficiency and Patent Owner provided no explanation for why the Goodman & Gilman statement is relevant to the issue at hand. Patent Owner also argued that one of ordinary skill would have been dissuaded from using reduced folates for treating folate deficiency because the prior art indicated that reduced folates were inferior to folic acid in several properties. The Board rejected this argument, finding that for each property, the evidence did not credibly support Patent Owner’s position.
The Board then examined Patent Owner’s arguments regarding the differences between the claimed subject matter and the prior art. Turning first to Serfontein, Patent Owner argued that a person of ordinary skill in the art would disregard Serfontein’s references to “a suitable active metabolite of folate” because it is vague and meaningless in that it encompasses so large a class of compounds. The Board found this argument unpersuasive because it only addresses the Serfontein disclosure, and not what the combination of the Serfontein and Marazza disclosures would have conveyed, and the Board found no evidence that Serfontein teaches away from the use of a “suitable active metabolite of folate.” The Board then discussed Patent Owner’s argument that Marazza does not suggest that reduced folate is better than folic acid, does not disclose using folates for lowering serum homocysteine levels, and does not explain the role of the unnatural isomer. The Board found these unpersuasive because Petitioner did not rely on Marazza for any of these disclosures. Patent Owner also argued that it would not have been obvious to combine the chirally-pure 5-methyl-(6S)-THFA disclosure with vitamin B12, but the Board found that Patent Owner offered no evidence for this other than the bare assertion by one of its experts.
The Board then examined Patent Owner’s evidence of secondary considerations, particularly commercial success, licensing, copying, long-felt but unmet need, discovering and solving an unrecognized problem, unexpected results, skepticism, and praise. However, the Board found that Patent Owner had not shown a nexus between the evidence of nonobviousness and the claimed invention. Specifically, Patent Owner argued that a nexus is established when the thing on which the evidence is based is “covered by the patent.” However, the Board found that a showing of nexus also involves establishing that novel elements in the claim, not prior art elements, account for the objective evidence put forward to show nonobviousness, and that was not established because Patent Owner did not provide objective evidence of nonobviousness for numerous species that would not work as the products presented work.
The Board then addressed the Motion to Amend. Patent Owner moved to cancel claim 37, and claims 39, 40, 47, 66, 67, 73, 76, 78-81, 83, 84, 86-89, 91, and 92 to the extent they depend from claim 37. Petitioner did not oppose, and the Board granted the Motion.
Finally, the Board addressed both parties’ Motions to Exclude Evidence. Patent Owner moved to exclude certain exhibits as inadmissible hearsay, but because the Board did not rely on those exhibits, it dismissed the Motion as moot. Petitioner moved to exclude various exhibits citing various provisions of the Federal Rules of Evidence. The Board denied the Motion, comparing itself to a bench trial in a district court where the Board is able to determine and assign appropriate weight to evidence. Therefore, the Board noted that in an IPR, the better course is to have a complete record of evidence for appellate review and denied the Motion.
Gnosis S.P.A., Gnosis Bioresearch S.A., and Gnosis U.S.A., Inc. v. South Alabama Medical Science Foundation, IPR2013-00116
Paper 68: Final Written Decision
Dated: June 20, 2014
Patent 5,997,915
Before: Jacqueline Wright Bonilla, Scott E. Kamholz, and Sheridan K. Snedden
Written by: Kamholz