Quest Diagnostics Investments LLC v. USPTO

Docket No. 2021-1115 (IPR2019-00738) (https://cafc.uscourts.gov/opinions-orders/21-1115.OPINION.12-27-2021_1885462.pdf) (Non-Precedential)

MOORE, CLEVENGER, STOLL

December 27, 2021

Brief Summary:  Board IPR decision of anticipation and obviousness of Quest’s claims affirmed.

Summary:  Quest appealed Board IPR decision that the challenged claims of US 8,409,862 relating to using mass spectrometry to detect low levels of testosterone in female humans including purifying the testosterone prior to mass spectrometry (MS).  With respect to this appeal, the Board found LabCorp showed claims 8 and 9 would have been obvious in view of Clark in combination with Draisci (both non-patent prior art).  Claims 8 and 9 claims methods “capable of detecting testosterone at concentrations of less than 5 ng/dL in the sample” and “less than 1 ng/dL in the sample,” respectively.  Clark is a meeting abstract that “details a method for detecting low levels of testosterone and describes a method similar to the ’862 patent—wherein testosterone is purified before” MS.  Quest argues in this appeal that Clarke was not “valid prior art as a printed publication” and the Board’s obviousness conclusion was incorrect. 

The Board found Clarke to be prior art as the meeting organizer (ASMS) “sent a CD containing Clarke to thousands of ASMS members, and that the CD was available in the University of Wisconsin-Madison library before the priority date of the ’862 patent” (“dissemination, accessibility, and searchability of the CD”).  Quest argued it “was a single abstract out of approximately 1,600, all with minimal indexing” (“an obscure, inaccessible reference”) but the FC panel disagreed as the distribution was “to the specific people most motivated to search the CD and find Clarke, a fact Quest does not dispute” and “permitted keyword searching” (Jazz Pharms., FC 2018; Suffolk, FC 2014 (“a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication”)). The Board also “found that a skilled artisan would have been motivated to achieve a lower level of detection and have reached these levels by optimizing several experimental parameters, specifically by “increasing the volume of the sample” and “modernizing the equipment.”  The FC panel found that “substantial evidence supports the Board’s conclusion that there was a motivation to improve the sensitivity of methods measuring testosterone” (e.g., “LabCorp’s expert testimony, as well as the scientific papers underlying that expert testimony to conclude that “measuring low testosterone levels are known to be clinically relevant”).  The FC panel similarly found substantial evidence supports the Board’s finding of a reasonable expectation of success (e.g., “Neither party disputes that increasing sample volume would increase level of detection, and experts for both parties agreed”; “unpersuaded by Quest’s argument that the alleged failure of others establishes nonobviousness”).  The Board’s decision was therefore affirmed.

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.