Intelligen Bio-Systems, Inc. v. Illumina Cambridge Ltd.

Docket No. 2015-1693 (IPR2013-00517)

May 9, 2016

Brief Summary: IBS’s initial petition found not to show a motivation to combine with a reasonable expectation of success and later-presented arguments to have been properly excluded by the Board (“the intial petition [must] identify ‘with particularlity’ the ‘evidence that supports the grounds for the challenge to each claim’”).

Summary: IBS appealed Board decision that it failed to show by a preponderance of the evidence that claims 1-6 and 8 of Illumina’s US 7,566,537 were obvious. The only independent claim (claim 1) is directed to “[a] method of labeling a nucleic acid molecule” where the “protecting group” thereof “can be modified or removed to expose a 3’ OH group and the protecting group comprises an azido group.” The Board construed claim 1 to “encompass[] the use of any protecting group attached via the 2’ or 3’ oxygen atom of a [sugar] moiety, in which the protecting group can be modified or removed to expose a 3’ OH group” (not requiring “quantitative deblocking” (at or near 100%)), which was not disputed. In this appeal, IBS argued the combinations of three references (Tsien, et al., Ju et al., and Zavgorodny et al.) rendered the claims obvious. In its Final Decision, the Board concluded IBS’s “‘Petition does not point to any specific evidence explaining why an ordinary artisan would have expected Zavgorodny’s azidomethyl protecting group to meet’ the quantitative deblocking requirement of Tsien…under conditions suitable for use in Tsien’s sequencing methods”. The Board also refused to consider IBS’s “new argument for the first time in its reply brief” (including an expert declaration regarding Zavgorodny) which “ran afoul of § 42.23(b)”. The FC opinion acknowledged “the Board’s precise legal underpinnings are difficult to discern” but explained “it appears to have relied on IBS’s failure to demonstate (1) a motivation to combine the relevant references, (2) that a person of ordinary skill would have a reasonable expectation of success of developing the claimed invention, or (3) both” and that “its ultimate conclusion is clear.” It found that the Board improperly considered the reasonable expectation of success as “whether one would reasonably expect the prior art references to operate as those references intended once combined” when the correct inquiry is whether one had “a motivation to combine accompanied by a reasonable expectation of achieving what is claimed in the patent-at-issue”. However, “[d]espite the loose language employed by the Board”, it found the Board’s “factual findings support its conclusion that the claimed are not invalid.” And the FC panel found “substantial evidence” that there was no “reason to combine” in view of two background references presented by Illumina that “support a conclusion that the claimed efficiency that allegedly motivated the combination [use in Tsien’s sequencing methods] would not be achieved” as “the azidomethyl group would have been expected to perform inefficiently”. The FC panel did not find error with the Board’s refusal to consider the “new argument”, warning petitioners “of the utmost importance…that the intial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’”

This entry was posted in Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.