Monday, December 27, 2021

Quest Diagnostics loses appeal of adverse IPR decision. ASMS abstract found to be a printed publication.

The outcome:

Quest Diagnostics Investments LLC (Quest) appeals a decision of the Patent Trial and Appeal Board (Board) in IPR2019-00738 finding claims 1, 2, and 4–14 of U.S. Patent No. 8,409,862 (the ’862 patent) unpatentable as either anticipated under 35 U.S.C. § 102 or obvious under 35 U.S.C. § 103. For the reasons stated herein, we affirm.

Of note:

[prior art]

Clarke is an abstract found on a compact disc (CD) from the 49th annual conference of the American Society for Mass Spectrometry (ASMS) held in May 2001. J.A. 1356– 57. 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. (...)

As to whether Clarke is a printed publication, the Board found Clarke was publicly available and therefore a prior art printed publication. Specifically, the Board recognized that the 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. See id. at *8–10. Further, the Board noted that although Clarke appeared alongside approximately 1,600 other abstracts, the CD permitted users to search the abstracts using selected keywords. See id. at *10. Given the dissemination, accessibility, and searchability of the CD, the Board found Clarke to be prior art. Id.

However, the ’862 patent explicitly excludes derivatization of testosterone before mass

Footnote 1

Quest explains that derivatization of testosterone is one method to improve detection of testosterone using mass spectrometry. See Appellant’s Br. at 6–7. However, Quest contends that the derivatization process can be laborious and time consuming. S

The CAFC said

The Board found that the ASMS widely disseminated the CD containing Clarke and that the CD was available in a university library. See Lab’y, 2020 WL 5224211, at *7– 10. Quest largely ignores the ASMS’s public dissemination and instead highlights that Clarke was a single abstract out of approximately 1,600, all with minimal indexing. See Appellant’s Br. at 43–45. Quest contends that this makes Clarke an obscure, inaccessible reference. We disagree


Nonetheless, given the wide dissemination of the CD, we are unpersuaded that any identified limitations in searchability require finding Clarke inaccessible. As this court has already held, “a printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.” Suffolk Techs., LLC v. AOL Inc., 752 F.3d 1358, 1365 (Fed. Cir. 2014). Accordingly, we conclude that substantial evidence supports the Board’s finding that Clarke was publicly available and thus prior art.


As an initial matter, the parties dispute which precise framework the Board applied in finding claims 8 and 9 obvious—either the “routine optimization” analysis or the “obvious-to-try” analysis. See Appellant’s Br. at 20–25. Regardless of this distinction, the Board articulated a clear motivation to modify and a clear reasonable expectation of success, see Lab’y, 2020 WL 5224211, at *18–20, findings that we conclude are supported by substantial evidence. Specifically, Quest argues 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. See Appellant’s Br. at 26–40. We find that substantial evidence supports the Board’s conclusion that there was a motivation to improve the sensitivity of methods measuring testosterone. The Board relied on 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.” Lab’y, 2020 WL 5224211, at *18–19 (citing, for example, J.A. 1228–29). Although Quest argues that 5 ng/dL and 1 ng/dL of testosterone are below the “‘clinically relevant’ range of testosterone,” we are unpersuaded this discourages developing more sensitive methods. Appellant’s Br. at 26. In sum, we find that the Board had substantial evidence to find a motivation to modify Clarke to reach 5 ng/dL and 1 ng/dL detection limits.


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