Earlier today, the Federal Circuit affirmed the final determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board finding claims 1, 2, and 4-14 of U.S. Patent No. 8,409,862 unpatentable as either anticipated or obvious.

The '862 patent is directed to using mass spectrometry to detect low levels of testosterone in female humans.  The '862 patent explains that while testosterone levels are much lower in females as compared to males, testosterone can be purified prior to mass spectrometry, which can improve the limit of detection.  Claims 8 and 9, which were relevant to the appeal, require the detection of testosterone at concentrations of less than 5 ng/dL or less than 1 ng/dL in the sample, respectively.

Laboratory Corporation of America Holdings had petitioned for inter partes review of the claims found by the Board to be unpatentable, arguing that claims 8 and 9 would have been obvious in view of Clarke, an abstract found on a CD from the 49th annual conference of the American Society for Mass Spectrometry (ASMS) held in May 2001, or as obvious in view of Clarke in combination with another reference (Draisci).  The opinion notes that "Clarke details a method for detecting low levels of testosterone and describes a method similar to the '862 patent—wherein testosterone is purified before mass spectrometry."  The opinion also notes that Clarke discloses the detection of testosterone down to 50 pg/mL, which is equivalent to 5 ng/dL.

On appeal, Quest argued that the Board erred with respect to two of its findings:  first, that Clarke was valid prior art as a printed publication, and second, that claims 8 and 9 would have been obvious in light of Clarke or Clarke in combination with Draisci.  Regarding the first determination, the Board noted that the ASMS sent the CD containing Clarke (and approximately 1,600 other abstracts) 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.  The Board also noted that the CD permitted users to search abstracts using certain keywords.  Regarding the second determination, the Board concluded that it would have been obvious to reach detection limits below 5 ng/dL and 1 ng/dL based on the teachings of Clarke or Clarke with Draisci, finding that a skilled artisan would have been motivated to achieve a lower level of detection and would have reached these levels by optimizing several experimental parameters (in particular, by increasing the volume of the sample and modernizing the equipment).

With regard to Clarke, Quest argued that this reference was not a printed publication because it was not publicly accessible.  In particular, Quest pointed out that Clarke was on a CD with approximately 1,600 other abstracts and that the CD provided minimal indexing, which made Clarke "an obscure, inaccessible reference."  The Federal Circuit, however, disagreed, stating that "although Clarke was surrounded by hundreds of other abstracts, the ASMS distributed the CD to the specific people most motivated to search the CD and find Clarke" (emphasis in opinion).  The Federal Circuit also noted that the CD allowed for some keyword searching using several mass spectrometry-related keywords, even if the keyword "testosterone" could not be searched.  The Federal Circuit therefore concluded that substantial evidence supported the Board's finding that Clarke was publicly available and thus prior art.

With regard to the Board's finding of obviousness with respect to claims 8 and 9, Quest argued that there was no motivation to modify Clarke to increase sensitivity, that there was no reasonable expectation of success in doing so, and that there was a documented failure of others.  The Federal Circuit first found that substantial evidence supported the Board's conclusion that there was a motivation to improve the sensitivity of methods measuring testosterone.  Quest had specifically argued that 5 ng/dL and 1 ng/dL of testosterone are below the clinically relevant range of testosterone, but the Court was unpersuaded that this would have discouraged the development of more sensitive methods.  The Court next found that substantial evidence supported the Board's finding that a skilled artisan would have had a reasonable expectation of success of achieving a lower level of detection, noting that the Board had recognized a number of parameters, including increasing the sample volume, that a skilled artisan could have modified to reach 5 ng/dL or 1 ng/dL detection.  Finally, the Court was unpersuaded by Quest's argument that Kushnir et al., 52(1) CLIN. CHEM. 120–28 (2006), demonstrated a failure of others to reach detection levels of 5 ng/dL or 1 ng/dL without derivatizing testosterone.  "Given the deferential standard of review, as well as the differences in Kushnir's detection method relative to the claims at issue," the Board "decline[d] to say that the Board erred in determining that Kushnir fails to establish nonobviousness."  The Federal Circuit therefore found that substantial evidence supported the facts underlying the Board's conclusion that claims 8 and 9 would have been obvious in view of Clarke.

Finding that substantial evidence supported both of the Board's findings that were challenged by Quest, the Federal Circuit affirmed the Board's finding that claims 1, 2, and 4–14 of the '862 patent were unpatentable as either obvious or anticipated.

Quest Diagnostics Investments LLC v. Hirshfeld (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Chief Judge Moore and Circuit Judges Clevenger and Chen
Opinion by Circuit Judge Chen