Alere, Inc. v. Rembrandt Diagnostics, LP

Docket Nos. 2018-1812 (IPR2016-01502)
NEWMAN, DYK, REYNA
October 29, 2019
Non-Precedential

Brief Summary: Board’s claim construction of the “wherein” clause affirmed; decision remanded for consideration of non-instituted grounds.

Summary: Alere appealed Board IPR final written decision (FWD) finding certain challenged claims of Rembrandt’s US 6,548,019 regarding “[a] device for collecting and assaying a sample of biological fluid” not unpatentable for obviousness. Claim 1 of the ‘019 patent includes a “wherein” clause describing the position of the “flow control channel” and how liquid flows through the device. Alere petitioned for IPR challenging claims 1-6 and 9-15 on 13 grounds, and the Board instituted review of claims 1-5, 9 and 11-15 on certain grounds but not others. Rembrandt then disclaimed claims 1, 9, and 11-15, leaving claims 2-5 in the IPR. The Board concluded that Alere had shown claim 2, but not claims 3-5 to be unpatentable. Alere argued this is incorrect since the Board erred in its construction of the “wherein” clause, which the Board found to be “consistent with the plain language of the claim and disclosures in the specification.” The FC panel agreed with the Board’s claim construction under the Phillips (FC 2005) or broadest reasonable interpretation standards (see FN1), and found it to be consistent with the “functional language that informs us of the structural requirements of the claim” (K-2 Corp., FC 1999) as well as the specification (“apparent from the figures and corresponding portions of the written description…No figure shows a device incapable of having fluid added after a flow control channel is placed inside…nothing in the specification is inconsistent”). The FC panel also explained that “[t]he Board’s construction is also consistent with the title and the abstract…which describe the invention as a ‘single-step’ collecting and assaying device” and “the claim language does not create a process limitation” (“As the Board pointed out, the claim recites a device, not a method-an important distinction.” (IPXL Holdings, FC 2005; Hewlett-Packard, FC 1990 (“apparatus claims cover what a device is, not what a device does”)). The FC panel therefore affirmed the Board’s claim construction of the “wherein” clause. Altere and Rembrandt agreed that Alere is entitled to remand under SAS (US 2018) “in order for the Board to consider the non-instituted claims and grounds in the petition”, and the FC panel concluded “that the better course of action in this case is to remand without addressing the merits of the patentability challenges” (BioDelivery, FC 2018 (not addressing the merits); Medtronic, FC 2018 (addressing the merits)).

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.