Biogen case: poorly-phrased prosecution argument as disclaimer?

The STRATEGY in the Biogen case is similar to what was employed by Butamax in the Gevo case:

Biogen Idec Inc. and Genentech, Inc. (collectively, “Biogen”)
seek review of the district court’s construction of
the disputed claim term “anti-CD20 antibody” that narrowed
the term based on prosecution history disclaimer.
Under that construction, Biogen stipulated that it could
not prove infringement by GlaxoSmithKline LLC and
Glaxo Group Ltd. (collectively, “GSK”). Biogen took that
approach in order to appeal the district court’s claim
construction. We conclude that the district court did not
err in finding a clear and unmistakable disclaimer and,
therefore, we affirm.

Enablement was an issue in prosecution in the Biogen case:

During prosecution of the ’612 patent, the examiner
rejected all the claims because the specification did not
provide enablement commensurate with the scope of the
claimed invention, which, under the “broadest reasonable
interpretation” standard applied by the U.S. Patent and
Trademark Office (PTO), included “any and all anti-CD20
antibodies, no matter the specificity or affinity for the
specific epitope on the circulating tumor cells.”

The issue presented in the case:

The
district court, however, adopted GSK’s construction of
“rituximab and antibodies that bind to the same epitope
of the CD20 antigen with similar affinity and specificity
as rituximab.” Biogen, 2011 U.S. Dist. LEXIS 120043, at
*31. It based this conclusion on prosecution history
disclaimer wherein Biogen limited that term to overcome
the examiner’s enablement rejection. Following this
construction, which excluded GSK’s accused Arzerra®
product, Biogen stipulated to noninfringement, and on
November 15, 2011, the court entered judgment against
Biogen under Federal Rule of Civil Procedure 54(b).
Biogen subsequently appealed to this court.

Concerning disavowal:

But a term’s ordinary meaning must be considered
in the context of all the intrinsic evidence, including
the claims, specification, and prosecution history. 3M
Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d
1365, 1371 (Fed. Cir. 2003); see also Phillips, 415 F.3d at
1314. “[T]he prosecution history can often inform the
meaning of the claim language by demonstrating how the
inventor understood the invention and whether the inventor
limited the invention in the course of prosecution,
making the claim scope narrower than it would otherwise
be.” Phillips, 415 F.3d at 1317. In the latter circumstance,
we have recognized that a “clear and unmistakable”
disavowal during prosecution overcomes the “‘heavy
presumption’ that claim terms carry their full ordinary
and customary meaning.” Omega Eng’g, Inc. v. Raytek
Corp., 334 F.3d 1314, 1323, 1326 (Fed. Cir. 2003); see also
Epistar Corp. v. Int’l Trade Comm’n, 566 F.3d 1321, 1334
(Fed. Cir. 2009) (“A heavy presumption exists that claim
terms carry their full ordinary and customary meaning,
unless it can be shown the patentee expressly relinquished
claim scope.” (emphasis added)). Thus, when the patentee
unequivocally and unambiguously disavows a certain
meaning to obtain a patent, the doctrine of prosecution
history disclaimer narrows the meaning of the claim
consistent with the scope of the claim surrendered. Id. at
1324.

How the response to the enablement rejection played out in the
later litigation:

according to the examiner,
the specification only enabled Rituxan®, rituximab,
and 2B8-MX-DTPA.4 It was not enabling for other anti-
CD20 antibodies, which had different structural and
functional properties.

In response, rather than challenging the examiner’s
understanding of the crucial terms, the applicants argued
that the specification was enabling for anti-CD20 antibodies
with similar affinity and specificity as Rituxan®.
Indeed, the applicants conceded that other “antibodies
directed to the same antigen [i.e., CD20] might have
different affinities and functional characteristics,” and
limited their claims to antibodies similar to Rituxan®
nonetheless. Joint App’x 324.

Footnote 5:

Pointing to another portion of the prosecution history,
Biogen maintains that the novel aspect of the ’612
patent is its recognition that any anti-CD20 antibody
could treat CLL. Joint App’x 325. This argument, however,
does not alter our analysis where the applicants
overcame the examiner’s enablement rejection by explicitly
relinquishing claim scope. See Computer Docking
Station, 519 F.3d at 1377 (“[A] disavowal, if clear and
unambiguous, can lie in a single distinction among
many.”).

Of guidance in prosecution:

While disavowing statements must
be “so clear as to show reasonable clarity and deliberateness,”
Omega, 334 F.3d at 1325, this requirement does not
require the applicant to parrot back language used by the
examiner when clearly and deliberately responding to a
particular grounds for rejection. If an applicant chooses,
she can challenge an examiner’s characterization in order
to avoid any chance for disclaimer, but the applicants in
this case did not directly challenge the examiner’s characterization.
See TorPharm Inc. v. Ranbaxy Pharm., Inc.,
336 F.3d 1322, 1330 (Fed. Cir. 2003) (“Whether the patentee
chooses to dispute the examiner’s view of matters
is relevant to claim interpretation, for there a court may
need to ascertain exactly what subject matter was actually
examined and allowed by the PTO.”). Rather, they
simply discussed specificity and affinity with regard to
the disclosure of the ’612 patent, which was narrowly
limited to Rituxan®, rituximab, and 2B8-MX-DTPA.

Discussion of the "statement of reasons for allowance" arose

Those cases typically involve an applicant
standing silent when confronted by statements made
by the examiner during prosecution, most often in the
examiner’s Statement of Reasons for Allowance. See, e.g.,
Salazar v. Procter & Gamble Co., 414 F.3d 1342, 1345–47
(Fed. Cir. 2005); ACCO Brands, Inc. v. Micro Sec. Devices,
Inc., 346 F.3d 1075, 1079 (Fed. Cir. 2003). This case deals
not only with applicants letting stand an examiner’s
narrow characterization of a claim term, but also their
adoption of that characterization to overcome the examiner’s
enablement rejection. Thus, the acquiescence cases
are inapposite. See TorPharm, 336 F.3d at 1330 (“[T]he
public is entitled to equate an inventor’s acquiescence to
the examiner’s narrow view of patentable subject matter
with abandonment of the rest.”).

Incorporation by reference was discussed:

Second, Biogen contends that because the ’612 patent
incorporated the ’137 patent by reference, the latter
patent’s definition of “anti-CD20 antibody” should control.
The problem with this argument is that the ’137 patent
expressly and uniquely defines “anti-CD20 antibody” for
use therein, that is, within the ’137 patent. ’137 patent
col. 6 l. 65 (“As used herein, the term ‘anti-CD20 antibody’
is . . . .” (emphasis added)). The definition, therefore, does
not necessarily reflect how a person of ordinary skill in
the art would understand the disputed term in the context
of the ’612 patent. See Phillips, 415 F.3d at 1313.
Rather, it may very well be that this is a “special definition
given to a claim term by the patentee that differs
from the meaning it would otherwise possess.” Id. at
1316. Even assuming the ’137 patent conveyed “anti-C20
antibody’s” plain and ordinary meaning, this is a case
where prosecution history disclaimer overcomes the
presumption of plain and ordinary meaning as we concluded
above.

Judge Plager dissented:

Because I do not find anywhere in the majority opinion
or in the prosecution history that clear and unmistakable
evidence of a disclaimer as required by our
precedents, I cannot agree with the majority that such a
disclaimer was made by Biogen during the prosecution of
its application for the ’612 patent; I respectfully dissent.

AND

However, the give-and-take that is often part
of the process of negotiation between an examiner and an
applicant may result in less-than-clear understandings,
as happened here. Making too much of such ambiguous
statements “does not advance the patent’s notice function
or justify public reliance.” SanDisk Corp. v. Memorex
Products, Inc., 415 F.3d 1278, 1287 (Fed. Cir. 2005).
Accordingly, we have consistently declined to invoke the
doctrine of prosecution disclaimer in the absence of “an
unambiguous disavowal that clearly and unmistakably
disclaims” the plain meaning of a disputed claim term.
Grober v. Mako Prods., Inc., 686 F.3d 1335, 1342 (Fed.
Cir. 2012) (emphasis added).

AND

By ignoring most of the prosecution history and reading
something into the above dialogue between the examiner
and the applicants that is not there, it is possible to
argue, as GSK has done, that the “anti-CD20 antibodies”
that may be used in the claimed methods are limited to
only RITUXAN®-like antibodies. But it is at least equally
possible, and more correct, to read the applicants’ prosecution
arguments as contemplating the use of antibodies
other than RITUXAN®-like antibodies. And when a
prosecution argument is subject to more than one reasonable
interpretation, it cannot rise to the level of a clear
and unmistakable disclaimer. 01 Communique Lab. Inc.
v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012).
We have long followed the rule that even a poorly-phrased
prosecution argument does not a disclaimer make.



Relevant keyword: RITUXAN® (rituximab)