2012年8月25日星期六

Review and Analysis of Lab. Corp. of Am. Holdings

Damaged Supra For Sale, I. SUMMARY

This case has to do with \"correlation\" claims, particularly for medical technology, but Damaged Supra For Sale applicable to other technologies as well. In addition, it provides useful guidance on how the Supreme Court will receive the Court of Appeals for the Federal Circuit\'s \"useful, concrete, and tangible result\" test for compliance with 35 USC 101.

II. FACTS

In this case, the Supreme Court granted cert., and then dismissed (a \"DIG\"; Dismissal for Improvident Grant of Certiori). The Supreme Court concluded that the issue raised in the appellant\'s brief had not been argued in the courts below (district court and Federal Circuit), and therefore was not entitled to consideration. The issue raised by the appellants in their brief to the Supreme Court was whether claim 13 met the 35 USC 101 requirement for statutory subject matter, and did not claim merely a law of nature. Although the Supremes DIG\'d this case, the Chief Justice did not participate, and there was a three Justice dissent (Justices Breyer, Stevens and Souter). The dissent\'s opinion explains why it dissents, but more importantly, explains why on the merits it would have held claim 13 invalid. Since the views of the other 5 justices on the merits are unknown, it may be that the opinion of the dissent, on the merits, is a majority view of the Court! Hence, it is instructive to review the claim at issue, and the reasons why the dissent would have found this claim unpatentable. Claim 13 reads as follows:

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.

Both parties construed \"correlating\" to read upon the mental impression of a doctor recognizing that the level identified by the assay was \"an elevated level of total homocysteine\" compared to a normal level of total homocysteine. It was also established that, since Damaged Supra For Sale the normal level of total homocysteine was well known, any doctor seeing a result of an assay for total homocysteine would immediately Damaged Supra For Sale recognize if that level was an elevated level. Under those facts, the dissent opined on whether claim 13 was 35 USC 101 statutory subject matter as follows:

I turn to the merits. The researchers who obtained the present patent found that an elevated level of homocysteine in a warm-blooded animal is correlated with folate and cobalamin deficiencies. As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors\' efforts to use that correlation to diagnose vitamin deficiencies in a patient. Does the law permit such protection or does claim 13, in the circumstances, amount to an invalid effort to patent a \"phenomenon of nature\"?