The opinion of the court was delivered by: Jed S. Rakoff, United States District Judge.
As every sometime athlete is acutely aware, tears to
the menisci — the gristle-like structures that act as shock
absorbers to the knees — are painfully common. Until relatively
recently, the form of suture commonly used in repairing such
tears was a large surgical staple. In 1989, however, plaintiff
Saul N. Schreiber, M.D., patented a smaller, less cumbersome
alternative known as the Bionx Meniscus Arrow (the "Arrow") —
essentially a small plastic nail
with swept-back barbs to hold
the suture in place. Manufactured by co-plaintiff Bionx
Implants, Oy, a Finnish corporation, and marketed and distributed
in the United States by co-plaintiff Bionx Implants, Inc., the
Arrow soon became the suture of choice for meniscal repairs.
In 1996, however, defendant Linvatec Corporation began
marketing an alternative suture known as the Linvatec BioStinger
(the "BioStinger"). Like the Arrow, the BioStinger consists of a
small plastic shaft with swept-back barbs. Unlike the Arrow,
however, the BioStinger is somewhat flexible and has a hole
running lengthwise through its interior, thereby permitting
methods of insertion not normally available with the Arrow.
Contending, in effect, that these differences are inconsequential
so far as the Arrow's patent protection is concerned, Dr.
Schreiber and the Bionx companies brought suit against Linvatec
for patent infringement.
Following discovery, both sides moved for summary
judgment on their respective behalfs. While their well-wrought
submissions raised many interesting issues, the Court concludes
that it need not reach most of these issues because the relative
flexibility of the BioStinger is sufficient in itself to compel
summary judgment in defendant's favor.
Although the Arrow patent, No. 4, 873, 976 (the "'976
Patent") includes thirty-one claims, all define the patented
device as "rigid," specifically:
a single unit suture for body tissue repair comprising:
— a solid base member for seating against an exterior
surface of said tissue;
— a single rigid shaft portion upstanding from and
integrally connected to said base member adapted for
insertion into said tissue; and
— barb means integrally connected to said shaft portion to
aid in insertion of said shaft portion into said tissue
and to lock said shaft portion into said tissue.
Pl. Ex. 1, col. 4.32-41.*fn1 Thus, a similar device that is not
rigid would not infringe this patent. See Southwall
Technologies, Inc. v. Cardinal IG Co. 54 F.3d 1570, 1575 (Fed.
Upon even brief inspection, it is apparent that the
Arrow is "rigid" in the ordinary sense of stiff or brittle, while
the BioStinger is notably more flexible.*fn2 More to the point, the
language and history of the '976 Patent show that it is premised
on a meaning of "rigid" that precludes its application to the
BioStinger. To begin with, to qualify as "rigid" within the
specifications of the '976 Patent, a suture must be designed to
be pushed through tissue. See patent specifications at Pl. Ex.1,
col. 2.66-3.1 ("[s]utures, in accordance with the invention . . .
are formed of a material
having sufficient rigidity to allow the
sutures to be pushed through the tissues to be repaired."). The
BioStinger, however, is designed, not to be pushed through tissue
like the Arrow, but rather to be inserted into a precut channel
created by a guide needle. Although the BiosStinger, despite its
flexibility, has sufficient cohesion that its insertion down the
precut channel may slightly widen that channel, this is a far cry
from being designed, like the Arrow, with the rigidity necessary
to be pushed directly through the semi-hard cartilage of a
meniscus without any precutting.
Moreover, in his successful effort to obtain the '976
patent, Dr. Schreiber submitted an affidavit to the Patent Office
stating that the patent should be granted notwithstanding the
prior patenting of a suture known as the "Kronenthal device,"
because "[t]he Kronenthal et al. suture is not a rigid type of
suture as I have disclosed and claimed in my above noted patent
application, but is a flexible type of filament which cannot by
itself be pushed into a body tissue without the use of a needle."
Pl. Ex. 10 at 0046 (emphasis added). Such "prosecution history"
clearly shows that the use of the term "rigid" in the Arrow
patent was intended to distinguish that device from other
devices, such as the Kronenthal device and (now) the BioStinger,
that were designed to be inserted in needle-cut channels. See
generally, York Products, Inc. v. Central Tractor Farm & Family
Center, 99 F.3d 1568, 1575 (Fed. Cir. 1996).*fn3
Notwithstanding the foregoing, plaintiffs argue that
the BioStinger is not sufficiently non-rigid to be distinguished
from the Arrow because, whatever the differences in the
contemplated methods of insertion,*fn4 the BioStinger is at least
capable of being pushed through meniscus tissue and the Arrow is
at least capable of being inserted through a pre-cut channel.
The latter, however, is irrelevant, since even devices that
plaintiffs concede are not "rigid" can be inserted through precut
channels — the prior Kronenthal device that Dr. Schreiber
sought to distinguish being a prime example, see Def. Ex. 0, col.
5.14-18. As for the former argument, while plaintiffs
effectively concede that, apart from this litigation, the
BioStinger has never been inserted into meniscal tissue without
the use of the channel-cutting needle with which it is sold, see,
e.g., Pl. Opp. to Def. 56.1 Stmt. on Rigidity ¶¶ 236, 247,
plaintiffs nevertheless offer a videotape, specially prepared for
this case, that shows, they allege, that the BioStinger is
capable of being pushed into uncut meniscal tissue.
The insertion in the videotape, however, is made possible
only by use of a special "insertion rod" that plaintiffs
concede was designed specifically for the videotaped
demonstration. Pl. Opp. to Def. 56.1 Stmt. on Rigidity ¶ 255,
262; Pl. Ex. 4 (videotaped demonstration). It thus runs afoul of
the well-established rule that a device does not infringe merely
because it can be altered to make it infringe, as "the question
is not what a device might have been made to do, but what it was
intended to do and did do." High Tech Medical Instrumentation,
Inc. v. New Image Industries, Inc., 49 F.3d 1551, 1555 (Fed. Cir.
1995) (internal quotation marks omitted); see also Stryker Corp.
v. Davol, Inc., 10 F. Supp.2d ...