QXMedical, LLC v. Vascular Solutions, LLC

Background

The case concerns six patents covering guide extension catheters, medical devices used to help deliver balloons or stents into narrowed coronary arteries. Teleflex Innovations S.À.R.L. owns the patents, Vascular Solutions, LLC’s parent corporation acquired Vascular Solutions in February 2017, and Arrow International, Inc. has the right to sell products practicing the patents. The court referred to the defendants collectively as “Vascular Solutions.”

After Vascular Solutions accused QXMÉDICAL, LLC of patent infringement, QXMÉDICAL sought declarations that its Boosting Catheter did not infringe the patents and that the patents were invalid. Vascular Solutions counterclaimed for infringement. After claim construction and discovery, both sides moved for summary judgment, which is judgment without a trial when there is no genuine dispute over a material fact and the moving party is entitled to judgment under the law.

Indefiniteness

QXMÉDICAL argued that claims requiring a “substantially rigid” pushrod were indefinite. The court had previously construed “substantially rigid” to mean “rigid enough to allow the device to be advanced within the guide catheter.” The court rejected QXMÉDICAL’s argument that “substantially rigid” and “flexible” had to be mutually exclusive. The claims required the pushrod to be more rigid than the flexible tip, and experts for both sides agreed that a skilled person could apply those requirements. The court granted Vascular Solutions summary judgment that the asserted claims were not invalid for indefiniteness.

Recapture Rule

The “recapture rule” prevents a patent owner from using a reissued patent to reclaim subject matter surrendered to obtain the original patent. The original ’032 patent required a pushrod “without a lumen,” while the RE’760, RE’776, and RE’116 reissued patents did not include that limitation.

The parties agreed that the reissued claims were broader because they covered pushrods both with and without lumens. The court held that the prosecution history did not provide clear and convincing evidence that Vascular Solutions had surrendered pushrods with lumens to overcome prior art. The “without a lumen” limitation had been proposed by the examiner, and the prior art already disclosed pushrods without lumens. The court therefore granted Vascular Solutions summary judgment that the RE’760, RE’776, and RE’116 patents did not violate the recapture rule.

Infringement involving a lumen

The ’032, ’413, and RE’380 patents require a pushrod “without a lumen.” Vascular Solutions argued that the Boosting Catheter literally satisfied that limitation; QXMÉDICAL argued that it had a lumen. The court found that a reasonable jury could agree with either side and denied both summary-judgment motions on literal infringement.

Vascular Solutions also argued that the Boosting Catheter infringed under the doctrine of equivalents, a rule that can treat a product element as infringing when it performs substantially the same function in substantially the same way despite not literally meeting a claim limitation. Conflicting expert reports concerned whether the catheter’s microscopic hollow space was equivalent to a pushrod without a lumen. The court held that this issue also had to be tried to a jury. The court did not decide QXMÉDICAL’s legal defenses to that theory because their resolution might not be necessary after the jury’s findings.

One-French limitation

Certain claims required the guide extension catheter’s inner diameter to be no more than one French smaller than the inner diameter of the guide catheter. Vascular Solutions alleged that QXMÉDICAL’s 6F Boosting Catheter directly infringed apparatus claims and that QXMÉDICAL induced surgeons to infringe system and method claims.

The court held that the “for use with” language described the device’s capability, but the one-French requirement was a structural limitation. The 6F Boosting Catheter, as manufactured, did not include a guide catheter. A surgeon later chose which guide catheter to pair with it, and QXMÉDICAL did not control that choice. The court therefore granted QXMÉDICAL summary judgment that the Boosting Catheter did not directly infringe the apparatus claims containing the one-French limitation. The court noted that Vascular Solutions’s argument that QXMÉDICAL infringed during product testing lacked enough factual and legal support for a ruling as a matter of law, so that claim would have to be tried.

The court found one instance in which Dr. Yale Wang, a heart surgeon affiliated with QXMÉDICAL, performed the claimed steps while using the 6F Boosting Catheter with a .070-inch guide catheter. But induced infringement also required proof that QXMÉDICAL took an affirmative action, with specific intent to cause that infringement, and that the action led to the infringement. The court found no such evidence. It granted QXMÉDICAL summary judgment on Vascular Solutions’s induced-infringement claims.

Side-opening limitation

Several reissued patents required the catheter’s side opening to be more rigid than the tubular structure. QXMÉDICAL argued that marker bands near the side opening made that limitation unsatisfied. The court held that QXMÉDICAL had not adequately disclosed this “marker-band defense” in its required claim chart. Because the late disclosure violated the pretrial scheduling order and would prejudice Vascular Solutions and interfere with case management, the court barred QXMÉDICAL from asserting the defense.

Because the marker-band defense was QXMÉDICAL’s only defense to Vascular Solutions’s motion on this issue, the court granted Vascular Solutions summary judgment that the Boosting Catheter met the side-opening limitations of claims 25 and 48 of the RE’760 patent, claims 25 and 52 of the RE’776 patent, and claim 52 of the RE’116 patent.

Anticipation

QXMÉDICAL argued that claim 53 of the RE’116 patent was invalid because it was anticipated by U.S. Patent No. 5,527,292, known as Adams. Anticipation requires one prior-art reference to disclose every limitation of the claim.

The court first barred QXMÉDICAL from presenting the Adams defense because its pretrial disclosures did not explain how Adams disclosed each limitation, including the more-rigid side-opening requirement. The court also addressed the merits and held that Adams did not anticipate claim 53. Adams disclosed an end opening formed by a perpendicular cut, while claim 53 required a side opening formed by an angled cut that exposed part of the tube’s side. The court granted Vascular Solutions summary judgment that claim 53 was not invalid as anticipated.

RE’776 infringement

Vascular Solutions sought summary judgment that the Boosting Catheter infringed claims 25, 36, 52, and 53 of the RE’776 patent. The court found that the catheter met the identified limitations, including the substantially rigid pushrod and the required inclined regions. The court granted Vascular Solutions’s motion for a declaration that QXMÉDICAL infringed those four claims.

Disposition

The court granted QXMÉDICAL’s summary-judgment motion in part and denied it in part. It granted the motion as to no infringement, and no induced infringement, of the specified claims containing the one-French limitation, and denied it in all other respects.

The court granted Vascular Solutions’s summary-judgment motion in part and denied it in part. It granted the motion concerning the asserted claims’ lack of indefiniteness; the lack of recapture-rule invalidity for the RE’760, RE’776, and RE’116 patents; the lack of anticipation of RE’116 claim 53; the specified side-opening limitations; and infringement of RE’776 claims 25, 36, 52, and 53. It denied the motion in all other respects. Infringement of the asserted “without a lumen” claims, literally or under the doctrine of equivalents, remained for a jury.