Tuesday, October 29, 2019

The CAFC discusses "wherein" clauses in Alere v. Rembrandt

The outcome of Alere v. Rembrandt:

Alere, Inc., appeals from a final written decision of the
Patent Trial and Appeal Board in an inter partes review
proceeding, upholding certain challenged claims as not unpatentable.
We conclude that the Board correctly construed the disputed “wherein” clause in claim 1 and affirm
that limited portion of the Board’s final written decision.
Because the Board improperly declined to institute review
on certain claims and grounds included in Alere’s petition
and its final written decision did not address those claims
and grounds, we vacate the remaining aspects of the final
written decision and remand for further proceedings.

The judicial standards:

The Administrative Procedure Act (“APA”) at 5 U.S.C.
§ 706(2) guides our review of Board decisions. Dickinson v.
Zurko, 527 U.S. 150, 152, 165 (1999). Under the APA, we
review the Board’s legal determinations de novo and its factual findings
for substantial evidence. ACCO Brands Corp.
v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir. 2016). As
such, we review the Board’s ultimate determinations on
claim construction de novo and any subsidiary factual findings for substantial evidence.
HTC Corp. v. Cellular
Commc’ns Equip., LLC, 877 F.3d 1361, 1367 (Fed. Cir.

As to the "wherein" clause:

We start with the plain language of the claim.1 Phillips
v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005). The
disputed “wherein” clause is found in claim 1 and states:
wherein the flow control channel is disposed inside
the sample fluid container with the liquid pervious
side oriented toward the base of the sample fluid
container so that the assay sample fluid, when
added to the container, is delivered to the sample
loading zone of the assay test strip by entry through
a liquid pervious side of the flow control channel
without migration through an intermediate structure . . . .
’019 patent col. 8 ll. 57–64 (emphases added). This clause
includes functional language that informs us of the structural requirements
of the claim. K-2 Corp. v. Salomon S.A.,
191 F.3d 1356, 1363 (Fed. Cir. 1999). The most natural
reading of this claim language shows a functional limitation that simply
requires that in the claimed device, when
the flow control channel is in place (i.e., “disposed inside
the . . . container”), fluid can be “added to the container”
and “delivered to” the loading zone of the assay test strip
without migration through another structure. In other
words, when (1) the flow control channel is in place and (2)
fluid is added to the container, then the fluid is delivered
to the loading zone.


Nothing in the claim language excludes a container
that contains fluid before the flow control channel is disposed inside or imports a temporal limitation on when fluid
must be introduced into the container. As the Board
pointed out, the claim recites a device, not a method—an
important distinction. See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). Thus,
the claim language does not create a process limitation.

Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d
1464, 1468 (Fed. Cir. 1990) (stating that “apparatus claims
cover what a device is, not what a device does”). That the
written description includes examples of embodiments
where the flow control channel is placed into fluid already
in the container does not mean that the device disclosed is
incapable of allowing the addition of fluid after the flow
control channel is “disposed inside.” Further, there are no
embodiments that disclose devices without that capability.
Accordingly, nothing in the specification is inconsistent
with the requirement of being able to add fluid to the container once the flow control channel is placed inside.
The Board correctly construed the wherein clause as
creating a functional limitation for structural relationships
of the device. Accordingly, we agree with the Board’s construction of the “wherein” clause found in claim 1(c) as
“requir[ing] a structure that is capable of allowing liquid to
enter the container when the flow control channel is disposed therein and capable of directing this liquid to the
sample loading zone of the assay test strip without the liquid having to migrate through an intermediate structure.”

As to the remand issue:

The parties agree that Alere is entitled to remand under SAS Institute, Inc. v. Iancu, ––– U.S. ––––, 138 S.Ct.
1348, 200 L.Ed.2d 695 (2018) in order for the Board to consider the non-instituted claims and grounds in the petition.
The parties dispute whether we should first reach the merits of the unpatentability challenges for the instituted
claims and grounds. We have previously declined parties’
invitations to address the merits of instituted claims and
grounds before remanding partially instituted proceedings,
recognizing that, “[a]ppellate courts have historically disfavored piecemeal litigation and permitted appeals from
complete and final judgments only.” BioDelivery Scis. Int’l,
Inc. v. Aquestive Therapeutics, Inc., 898 F.3d 1205, 1210
(Fed. Cir. 2018) (quoting W.L. Gore & Assocs., Inc. v. Int’l
Med. Prosthetics Research Assocs., Inc., 975 F.2d 858, 861
(Fed. Cir. 1992)). Other panels of this court, however, have
taken a different approach, addressing the merits of the instituted claims and grounds and then remanding for the
Board to consider the non-instituted claims and grounds.
E.g., Medtronic, Inc. v. Barry, 891 F.3d 1368, 1371 n.1 (Fed.
Cir. 2018).
We conclude that the better course of action in this case
is to remand without addressing the merits of the patentability challenges. Here, there are both non-instituted
claims and non-instituted grounds. As Alere points out,
the Board did not institute review on the same claims at
issue in this appeal for four other challenges included in
the petition. The likelihood of having to review the Board’s
patentability determinations for some of the same claims
for different grounds after the Board considers all claims
and grounds included in the petition weighs in favor of
awaiting a “complete and final” decision without further
addressing the merits.


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