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May 31, 2000


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. Cir. 1995)

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 ...

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