J&J/Cordis prevail on appeal at CAFC over Saffran

The bottom line in Saffran v. Johnson & Johnson and Cordis

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We conclude that the
district court erroneously construed the claims of the ’760
patent and that, under the correct construction, Cordis is
entitled to a judgment of noninfringement as a matter of
law. Accordingly, we reverse.

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The winning attorney: GREGORY L. DISKANT, Patterson Belknap Webb & Tyler
LLP, of New York, New York, who argued for defendants/appellants.

Of some history: The case proceeded to trial and the jury returned a
verdict in favor of Saffran on January 28, 2011. Specifically,
the jury found that the ’760 patent was not proven
invalid; that Cordis had willfully infringed the ’760 patent
through the manufacture, use, and sale of its accused
stent products; and that Saffran was entitled to damages
totaling $482,000,000. Saffran v. Johnson & Johnson,
No. 2:07-cv-451, 2011 WL 1299607, at *1 (E.D. Tex. Mar.
31, 2011). After the verdict, Cordis moved for judgment
as a matter of law on invalidity, infringement, willfulness,
and damages. The district court held that sufficient
evidence supported the jury’s conclusions as to invalidity,
infringement, and damages, denying Cordis’s motions on
those grounds.

Some of the issues: On appeal, Cordis disputes, inter alia, the district
court’s construction of the claim limitations “device” and
“release means for release of an at least one treating
material in a directional manner.” Under the correct
constructions, according to Cordis, its products cannot be
found to infringe the ’760 patent as a matter of law.

Estoppel arose as to the meaning of "device":

We conclude that Saffran’s statements during prosecution
of the ’760 patent limit “device” to a continuous
sheet. On multiple occasions during prosecution, Saffran
sought to distinguish prior art by representing to the
examiner that “[t]he device used is a sheet rather than a
pre formed chamber (Gaskill).” J.A. 1100, 1119, 1127.
Saffran contends that his statements merely disclaimed
the rigid pre-formed chambers disclosed in U.S. Patent
4,911,717 (“Gaskill”) without further limiting the invention
to a sheet. While Saffran surely disclaimed preformed
chambers during prosecution, we disagree that his
statements have such limited import.

The CAFC further noted:

Even if, as Saffran suggests, the examiner had relied only
on the latter, that would not annul the remainder of his
statement. “Rather, as we have made clear, an applicant’s
argument that a prior art reference is distinguishable
on a particular ground can serve as a disclaimer of
claim scope even if the applicant distinguishes the reference
on other grounds as well.” Andersen Corp. v. Fiber
Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007).
Furthermore, the record before us makes clear that the
examiner shared Saffran’s stated view of the claimed
device as a continuous sheet. In recording his reasons for
allowance, the examiner noted that “[t]he claimed invention
embodies a unique method of [macromolecular restraint]
using a single flexible minimally porous sheet
layer.” J.A. 530.

To be sure, a prosecution disclaimer requires “clear
and unambiguous disavowal of claim scope,” Storage
Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 833 (Fed. Cir.
2003), but applicants rarely submit affirmative disclaim
ers along the lines of “I hereby disclaim the following . . .”
during prosecution and need not do so to meet the applicable
standard. In this case, Saffran’s unqualified assertion
that “the device used is a sheet” extends beyond
illuminating “how the inventor understood the invention,”
Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir.
2005) (en banc), to provide an affirmative definition for
the disputed term. Given such definitive statements
during prosecution, the interested public was entitled to
conclude that the “device” recited in the claims of the ’760
patent is a continuous sheet.

AND

Therefore, reading the claim term
“device” to both require a sheet and exclude stents having
open mesh holes “most naturally aligns with the patent’s
description of the invention.” Ormco Corp. v. Align Tech.,
Inc., 498 F.3d 1307, 1313 (Fed. Cir. 2007) (quoting Phillips,
415 F.3d at 1316).

As to "release means", one finds an interesting situation in which
"means" are chemical bonds:

Cordis argues that the district court erred in identifying
the corresponding structures disclosed in the ’760
patent. According to Cordis, the district court’s generic
construction is overbroad, erroneously sweeping undisclosed
types of “chemical bonds and linkages” into the
scope of the claims. Cordis contends that the correct
structure is a hydrolyzable bond—the only type of bond
identified in the ’760 patent for performing the claimed
directional drug release function.
In contrast, Saffran defends the district court’s construction
as correct under § 112, ¶ 6, arguing that the ’760
patent broadly discloses “chemical bonds and linkages” as
a clear category of structures that would be readily understood
by one of ordinary skill in the art as suitable for
performing the claimed function.
We conclude that although the district court correctly
identified the claimed function as “to release a drug
preferentially toward the damaged tissue,” it erred in
identifying the corresponding structure disclosed in the
specification. The claimed structure for the “release
means” limitation is correctly construed as a hydrolyzable
bond.

The CAFC limited to the corresponding structure:

Applying those standards, we agree with Cordis that
the types of bonds set forth in the ’760 patent as corresponding
to the claimed release function are limited to
hydrolyzable bonds.

AND

As we have explained,
however, “[a] patentee cannot avoid providing specificity
as to structure simply because someone of ordinary skill
in the art would be able to devise a means to perform the
claimed function.” Blackboard, Inc. v. Desire2Learn, Inc.,
574 F.3d 1371, 1385 (Fed. Cir. 2009). Under § 112, ¶ 6,
the question is not what structures a person of ordinary
skill in the art would know are capable of performing a
given function, but what structures are specifically disclosed
and tied to that function in the specification.

And thus Cordis/J&J escape infringement:

As described above, we agree with Cordis that the district
court misconstrued the “device” and “release means”
limitations of the asserted claims. Cordis further contends
that, applying the correct constructions, it is entitled
to a judgment of noninfringement as a matter of law.
Specifically, Cordis argues that its accused stents both
lack a sheet covering the open mesh holes between their
struts and lack a drug affixed to their surfaces via hydrolyzable
bonds and therefore cannot infringe the asserted
claims. We agree.

Judge Moore disagreed on the chemical bond part:

I join Judge Lourie’s opinion except for Parts II-A-2
and II-B-2. Respectfully, I conclude that the district court
adopted the correct claim construction of “release means.”
The only issue in dispute is the identification of the
corresponding structure for the release means. The
district court concluded that the corresponding structure
was “chemical bonds and linkages.” I agree. The specification
is clear: “[t]he rate of healing can be . . . accelerated
by attachment of a treating material, either
mechanically or by chemical bond, to the inner surface of
the device,” which includes a “method of medicine release
by chemical bond.” ’760 patent, col.22 l.4–7. This passage
directly associates the claimed “release means” with the
chemical bond structure, which is sufficiently specific to
satisfy § 112 ¶ 6. See, e.g., Med. Inst. & Diagnostics Corp.
v. Elekta AB, 344 F.3d 1205, 1213–14 (Fed. Cir. 2003)
(explaining that § 112 ¶ 6 requires only “some link between
a generic structural reference and a claimed function”
understandable to a person of skill in the art). I
simply cannot fathom what more the patentee must do “to
link or associate structure to function” so as to provide
“sufficient specificity.” Op. at 21–22. By limiting the
structure to “hydrolyzable bonds,” my colleagues punish
the patentee for providing a detailed description of his
preferred embodiment.