CAFC Vacates Section 112 Indefiniteness Ruling, Sending St. Jude Medical Back to Court

“For purposes of the definiteness inquiry, the problem patentees face by using descriptive words in their claims is not the potential breadth of those claims. It is whether the use of descriptive phrasing in the claim results in a claim that ‘fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’” – Judge Stoll

Indefiniteness- April 11, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Niazi Licensing Corp. v. St. Jude Medical S.C., Inc. in which the court affirmed most of a ruling from the District of Minnesota, including sanctions against Niazi for improper use of expert testimony, as well as a finding of no induced infringement by St. Jude on one of Niazi’s asserted patent claims. However, the Federal Circuit’s decision reversed the Minnesota district court’s ruling invalidating most patent claims asserted by Niazi for indefiniteness under Section 112. The CAFC found that Niazi’s asserted claims were not invalid simply for including descriptive words or terms of degree, as long as the intrinsic record and extrinsic evidence enable a skilled artisan to identify the boundaries of a claim’s scope.

District Court Nixes Most Niazi Patent Claims for Failure to Clarify Scope

The patent-at-issue in this case is U.S. Patent No. 6638268, Catheter to Cannulate the Coronary Sinus. Invented by Imran Niazi, the ‘268 patent covers a double catheter having a resilient outer catheter having shape memory and a hook-shaped distal end, and a pliable inner catheter slidably disposed within the outer catheter and of greater length than the outer catheter so that the inner catheter can be extended or retracted from the outer catheter. The invention is designed to cannulate, or introduce a tiny tube into, the coronary sinus, which often varies in shape and size among patients, for the treatment of congestive heart failure.

Niazi sued St. Jude in Minnesota district court but on claim construction, the court invalidated all but one of Niazi’s asserted claims under 35 U.S.C. § 112 for indefiniteness because they included the terms “resilient” and “pliable,” which did not clarify the scope of the ‘268 patent’s claims according to the district court. After both sides exchanged expert reports on the sole remaining patent claim in the infringement case, St. Jude moved to strike portions of the report on damages and infringement for relying on facts that weren’t disclosed by Niazi during fact discovery. The district court agreed, entering sanctions under Federal Rule of Civil Procedure 37 excluding the disputed portions of Niazi’s expert reports.

The district court subsequently granted St. Jude’s motion to exclude all of Niazi’s damages expert report under Federal Rule of Evidence 702 for failure to properly apportion value attributable to the claimed method remaining in the case. Finally, the district court also entered summary judgment in favor of St. Jude on Niazi’s induced infringement claim after finding that St. Jude’s instructions for use of the CPS Aim SL Slittable Inner Catheter taught the use of the catheter in ordered steps different from the order claimed by the ‘268 patent, and that many steps were optional and therefore St. Jude’s instructions did not induce infringement.

Indefiniteness: ‘Resilient’ and ‘Pliable’ Inform a Skilled Artisan in Light of Written Description, Dependent Claims

Much of the Federal Circuit’s opinion focused on the Minnesota district court’s Section 112 indefiniteness analysis. Citing to the U.S. Supreme Court’s major indefiniteness ruling in 2014’s Nautilus v. Biosig Instruments, the Federal Circuit acknowledged the reasonable certainty standard derived from that case sought to balance the “inherent limitations” of language with the need to provide clear notice of the subject matter claimed by a patent. At the Federal Circuit, several decisions following Nautilus have found that patentees need not claim an invention with mathematical precision and that descriptive terms and terms of degree can be found definite if the context of the invention provides enough certainty to a skilled artisan.

For purposes of the definiteness inquiry, the problem patentees face by using descriptive words in their claims is not the potential breadth of those claims. It is whether the use of descriptive phrasing in the claim results in a claim that ‘fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’

In the present appeal, the Federal Circuit found that both the “resilient” and the “pliable” claim terms do inform their meaning to a skilled artisan with reasonable certainty thanks in large part to the intrinsic evidence within the ‘268 patent itself. In the case of “resilient,” the Federal Circuit noted that dependent claims provide exemplary resilient materials, such as “a braided silastic.” The meaning of “resilient” was further informed by the written description of the ‘268 patent, which explains that the outer catheter has a “braided design” that provides for “torque control and resistance.” While the meaning of “pliable” was less informed by dependent claim terms, the written description identified silicone as a potential soft material for the inner catheter. The written description also explained that the inner catheter “has no longitudinal braiding, which makes it extremely flexible and able to conform to various shapes.”

Not only did the intrinsic record provide objective boundaries for determining the scope of the claims, extrinsic evidence of dictionary definitions provided by Niazi further supported the Federal Circuit’s conclusion that both “resilient” and “pliable,” while broad in definition, still had meanings that could be understood by a skilled artisan. St. Jude contended that the written description was inconsistent in describing the inner and outer catheters, as the specification states that both catheters “preferably have a predetermined shape and a certain degree of stiff[n]ess to maintain such shape during manipulation in the heart, but still flexible enough to bend when required.” However, the Federal Circuit held that the written description of the ‘268 patent as a whole allowed a skilled artisan to readily differentiate between a “resilient” outer catheter and a “pliable” inner catheter.

No Abuse of Discretion in Expert Report Exclusion or Attorney’s Fees Award

While the Federal Circuit affirmed the district court’s grant of summary judgment on Niazi’s induced infringement claims, it did so on different grounds than the lower court. Claim 11, the sole claim of the ‘268 patent left in the case after the Section 112 indefiniteness ruling, includes a series of five steps describing the insertion, advancement and withdrawal of the catheter from a patient’s coronary sinus. In the insertion and withdrawal steps, the district court had construed the term “catheter” to mean “double catheter,” but the Federal Circuit found that the method in claim 11 included no temporal requirement mandating that the outer and inner catheter be inserted simultaneously, so sequential insertion was also covered. However, St. Jude’s instructions for use of the allegedly infringing catheter taught the steps of inserting the inner catheter and the guidewire in an opposite order than is taught by claim 11 of the ‘268 patent. On those modified grounds, the Federal Circuit affirmed the Minnesota district court’s ruling that St. Jude did not infringe claim 11.

Niazi’s remaining arguments on appeal centered on the district court’s treatment of its expert reports, but the Federal Circuit found no abuse of discretion in either the exclusion of Niazi’s expert reports or the district court’s sanctions order. The Federal Circuit noted that the record showed no disclosure by Niazi of either the factual claim by its infringement expert that he himself had infringed the ‘268 patent by using St. Jude’s products, or of third-party databases on licensing agreements used by Niazi’s damages expert to justify his opinion on the reasonable royalty owed by St. Jude. Niazi’s non-disclosures deprived St. Jude of a meaningful opportunity to conduct discovery on those points, and the Federal Circuit agreed that those non-disclosures were not “substantially justified or harmless.”

The Federal Circuit affirmed the entry of monetary sanctions against Niazi for violating the district court’s exclusion order, upholding the district court’s award of attorney’s fee to St. Jude for expenses related to its motion to strike Niazi’s expert witness declarations submitted in support of its motion for summary judgment, which included assertions from Niazi’s expert witnesses that the court had already excluded. Further, the appellate court also found no abuse of discretion in the district court’s decision to exclude the report from Niazi’s damages expert, which the district court found unreliable for basing the royalty on sales of all St. Jude catheters, including those that were not part of the infringement dispute, without apportioning for non-infringing catheters.

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One comment so far.

  • [Avatar for MaxDrei]
    April 13, 2022 06:33 am

    As I understand it, these catheters are about four foot long (from point of entry in the thigh, right up to and into the heart). When one thinks about the pushability and torquability of the subject catheter, and compares it with i) an uncooked strand of spaghetti and ii) a well-boiled strand of spaghetti, it is clear that if the catheter is to work, both of its tubular outer catheter and its inner catheter wire have to be BOTH resilient and pliable.

    As to the materials of construction of the respective inner and outer strands, I should not wish to hazard a guess which of them is the more i) pliable or ii) resilient.

    As to shape memory, I do not see how this is relevant. The shape memory efect of a NITINOL stent is relied upon during its manufacture, not its use. In use, it is its super-elastic deformation capability (flexibility) that is important. If you squash it flat, and then release it, being super-resilient it bounces back to its cylindrical form (unlike a stainless steel stent which stays flat). If you needed a stent in your carotid artery, which stent material would you prefer?