The U.S. Patent and Trademark Office Board of Patent Appeals and Interferences (Board) recently reversed a final rejection in the reexamination of Competitive Technologies, Inc’s. U.S. Patent No. 4,940,658, for which the U.S. Supreme Court previously granted and subsequently dismissed certiorari over a spirited dissent by Justice Breyer. The Board found the rejection of claims lacked a sufficient factual basis to support the conclusion of obviousness. Ex parte Competitive Technologies, Inc., Appeal No. 09/5519 (B.P.A.I., July 30, 2009) (Spiegel, APJ).

Illustrative claim 13 of the patent was directed to “a method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.” The ’658 patent was licensed to Metabolite, which in turn sublicensed the patent to LabCorp. LabCorp originally performed total homocysteine assays under the sublicense, but later switched to an assay developed by Abbott Laboratories and discontinued royalty payments to Metabolite. In response, Metabolite sued LabCorp for infringement.

In requesting certiorari, LabCorp asserted that the ’658 patent was invalid under 35 U.S.C. §101 because it was attempting to patent a natural phenomenon. This came after a decision from the Federal Circuit rejecting LabCorp’s appeal alleging that claim 13 was invalid under §§ 112, 102 and 103.

In his dissent from the decision to dismiss certiorari, Justice Breyer contended that claim 13 was invalid no matter how narrowly the natural phenomenon doctrine is interpreted. In his view, there could be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 was a “natural phenomena,” citing respondent’s brief for the assertion that the correlation recited in claim 13 is an observable aspect of biochemistry in at least some human populations.

Reversing the examiner’s rejection of claim 13, the Board explained that the dispositive issue was whether the applied prior art teaches, or would have suggested, all of the claim limitations to one of ordinary skill in the art. The Board found that, according to the ‘658 patent, both cobalamin (vitamin B12) and folate deficiencies result in an elevated homocysteine level, but an elevated homocysteine level cannot distinguish between a folate and/or cobalamin deficiency. The primary reference was found to disclose a method to determine total homocysteine, but the three secondary references were not found to fairly teach or suggest a correlation between elevated total homocysteine levels and a folate deficiency, as recited in claim 13.

Basing its decision solely on the issue of obviousness under § 103(a) and not addressing whether or not the subject matter of claim 13 was patent eligible (per Justice Breyer’s dissent), the Board held that the examiner failed to provide a sufficient factual basis for her conclusion that the applied prior art teaches or suggests all of the claim limitations.