Niazi Licensing Corporation v. Boston Scientific Corp.

Background

Niazi Licensing Corporation brought two patent-infringement actions against Boston Scientific Corp. and St. Jude Medical S.C., Inc. Niazi alleged that the defendants directly infringed United States Patent No. 6,638,268, concerning a catheter system for use in the coronary sinus, and indirectly infringed by inducing medical professionals to infringe. Niazi asserted claims involving both the catheter’s configuration and methods for using it.

The order addressed three matters: St. Jude’s motion to strike Niazi’s infringement contentions, Boston Scientific’s motion to exclude two pieces of evidence from the claim-construction proceedings, and the parties’ requests for construction of 21 disputed patent terms or phrases. Claim construction is the court’s determination of the meaning and scope of patent claims. The order did not address the second step of an infringement case—comparing the construed claims with the accused products.

Motion to Strike

St. Jude argued that Niazi’s infringement contentions failed to identify an act of direct or indirect infringement. The court explained that the rules cited by St. Jude permit sanctions for violating a scheduling or pretrial order, but St. Jude did not argue that Niazi’s contentions were untimely. The court concluded that the cited rules and authorities did not establish that the alleged substantive deficiencies violated the scheduling order. It therefore declined to strike the contentions.

The court denied St. Jude’s motion to strike.

Motion to Exclude Evidence

Boston Scientific sought to exclude a Patent Trial and Appeal Board decision concerning institution of inter partes review in a related case and a declaration by Dr. Imran Niazi. The court assumed, without deciding, that the evidence may have been disclosed late but found the disclosure harmless because Boston Scientific knew or should have known the underlying substance of the evidence when claim-construction briefing began. The court considered Dr. Niazi’s declaration only regarding the state of the art and other objective matters, not his subjective intent as an inventor. The court also found that the record did not support Boston Scientific’s argument that the declaration was unsigned.

The court denied Boston Scientific’s motion to exclude evidence.

Indefiniteness of “Inner, Pliable Catheter”

St. Jude and Boston Scientific argued that the phrase “inner, pliable catheter” made Claims 1, 13, 18, and 24, and claims depending on them, indefinite. Niazi proposed construing the phrase to mean “a catheter that is easily bent, flexible.” A claim is indefinite when, read in light of the patent’s specification and prosecution history, it fails to inform a person skilled in the field about the invention’s scope with reasonable certainty.

The court held that “inner, pliable catheter” did not provide a meaningfully precise scope on its face. The specification described the inner catheter as made of soft, pliable material and as extremely flexible, but also stated that it preferably had some stiffness while remaining flexible enough to bend when required. The court found that these descriptions did not establish objective boundaries for the claimed degree of pliability. A single example of a silicone catheter also did not clarify the claim’s scope.

The court concluded that the record contained clear and convincing evidence that “inner, pliable catheter” was indefinite.

Indefiniteness of “Resilient”

The defendants also argued that “resilient,” as used in “outer, resilient catheter” and “resilient tube,” made the relevant claims indefinite. Niazi proposed using the ordinary meaning of resilient: “able to return to its original shape when undistorted.”

The court found that “resilient” did not clearly identify the scope of the claims. Although the specification described the outer catheter or tube as relatively stiff, braided, and made of braided silastic or similar material, it did not provide objective criteria for measuring resilience. The example of a braided silastic or similar material also did not give the public meaningful notice of the claimed scope.

The court held, by clear and convincing evidence, that “resilient,” as used in the disputed terms, rendered the claims containing it indefinite.

Claims Invalidated as Indefinite

Based on its rulings concerning “pliable” and “resilient,” the court held Claims 1, 13, 18, and 24 invalid as indefinite. It also held dependent Claims 14, 15, 19, 23, 25, 26, and 27 indefinite because they depended on those independent claims. The court did not reach the defendants’ remaining claim-construction arguments concerning those claims.

The court stated that only Claim 11 remained asserted against Boston Scientific and St. Jude.

Construction of “The Catheter” in Claim 11

Claim 11 describes a method for placing an electrical lead in a lateral branch of a coronary sinus vein using a double catheter with an outer catheter and an inner catheter. St. Jude argued that “the catheter” was indefinite because the claim did not previously identify a single catheter to which that phrase referred. Boston Scientific did not make that indefiniteness argument. Niazi argued that “the catheter” meant “the double catheter.”

The court recognized some ambiguity because Claim 11’s preamble refers to a double catheter and its inner and outer components. But the court examined the claim as a whole. It noted that when Claim 11 refers to the component parts in later steps, it specifically calls them the inner catheter or outer catheter. In that context, the court held that a person skilled in the field would understand “the catheter” to mean the double-catheter system.

The court construed “the catheter” in Claim 11 to mean “the double catheter.”

Order of Claim 11’s Method Steps

The parties agreed that the first step of Claim 11 must be inserting the catheter into the coronary sinus and that the last step must be withdrawing the catheter. They disputed whether the guide wire had to be advanced before the inner catheter was advanced.

The court held that Claim 11’s steps had to be performed in the listed order. Step 3 requires advancing the inner catheter “along the guide wire” into the branch vein. The court reasoned that this logically requires the guide wire to have been advanced through the outer catheter first, as described in Step 2.

The court therefore concluded that Claim 11 is infringed only when its steps are performed in the order listed. The order did not determine whether either defendant actually infringed Claim 11.

Disposition

Judge Wilhelmina M. Wright ordered that St. Jude’s motion to strike was denied, Boston Scientific’s motion to exclude evidence was denied, and the disputed terms of Patent No. 6,638,268 were construed as addressed in the order.