Rare Examiner Request Filed for Patent of LabCorp Fame

U.S. Patent 4,940,658 relates to an assay for Sulfhydryl Amino Acids and methods for detecting and distinguishing Cobalamin and Folic Acid deficiency. This patent previously made headlines as the subject of the 2005 Supreme Court appeal that sought to explore the patentable boundaries of  “natural phenomena.” Lab. Corp. of Am. Holdings v. Metabolite Labs., 126 S. Ct. 2921, 2921 (2006) (dismissing the writ of certiorari as improvidently granted). Specifically, the defendants argued that the patent related to detecting a natural phenomena, namely, a vitamin B12 deficiency.

In 2006, third party requester General Atomics sought ex parte patent reexamination of the ‘458 Patent.(90/008,305) Of course, as patent reexamination may only consider questions of validity that relate to patents or printed publications, statutory subject matter considerations were never at issue; instead, only prior art rejections were applied in the patent reexamination.

Initially, the USPTO rejected certain claims of the ‘658 Patent, forcing the Patentee to pursue the case to the BPAI (ex parte Competitive Technologies, Inc. and The Trustees of Columbia University (Appeal 2009-005519)). The BPAI reversed the examiner’s rejection of the claims in July of 2009. Once reversed, as per usual, the examiner was ordered to withdraw the rejections, and allow the patent to exit reexamination.

Instead, the examiner opted to file a very rare, request for rehearing.

MPEP 1214.04 provides that:

The examiner may request rehearing of the Board decision. Such a request should normally be made within 2 months of the receipt of the Board decision in the TC. The TC Director’s secretary should therefore date stamp all Board decisions upon receipt in the TC.

All requests by the examiner to the Board for rehearing of a decision must be approved by the TC Director and must also be forwarded to the Office of the Deputy Commissioner for Patent Examination Policy for approval before mailing.

The examiner’s request for rehearing (here), as required, was approved by both the Deputy Commissioner for Patent Examination Policy, and Director of the Central Reexamination Unit. In the request for rehearing, the examiner pointed to the evidence of record as supporting the obviousness rejection. 

In BPAI opinion of last Friday, the request was considered, but the Board refused to change their earlier decision. The Board stated that the record did not teach or suggest the specific interrelationship claimed. As can be appreciated by the significant signatory requirement, such requests are almost never filed. In this case, it may be that the patent’s notoriety prompted the exceptional treatment.