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8 June 2023MedtechMarisa Woutersen

Teleflex secures win over Medtronic in catheter patent case

Medtronic’s claims of “obviousness” over cardiologist’s device rejected | US Federal Circuit upholds Teleflex’s catheter technology patents.

The US Court of Appeals for the Federal Circuit has delivered a win for Teleflex, upholding rulings of the Patent Trial and Appeal Board (PTAB) in two precedential decisions (cases 21-2359 and 21-2357).

The court, led by Chief Judge Moore, rejected Medtronic’s appeal against the validity of Teleflex's patent claims for catheter technology.

The case centred around GuideLiner, Teleflex's coaxial extension catheter designed for cardiologists treating coronary artery disease. Coronary artery disease requires interventional cardiology procedures using guide catheters to deliver devices that alleviate narrowing arteries.

Medtronic contested the validity of Teleflex's patents protected the GuideLiner by filing a petition for inter partes review. It argued that the patents would have been obvious based on prior art references.

These references included a combination of US patent number 5,439,445 with US patent application publication number 2004/0010280, US patent number 7,604,612, US patent application publication number 2005/0015073, and Takahashi's prior art journal article.

The PTAB initiated the review process and issued final written decisions, deeming some of Teleflex's claims unpatentable. But the board also granted Teleflex's motions to introduce substitute claims, which were found to be non-unpatentable.

Side opening claims

One of the crucial aspects of case 21-2357 was the examination of Teleflex's side opening claims. Medtronic put forth that these claims were obvious based on prior art references.

However, Teleflex presented evidence of nonobviousness and objective signs of innovation, such as commercial success and industry recognition.

The PTAB ruled in favour of Teleflex, finding that Teleflex’s “strong objective evidence of nonobviousness overcame the close prima facie case and that Medtronic had failed to prove the side opening claims unpatentable”.

The Federal Circuit affirmed this decision, acknowledging the substantial evidence supporting the PTAB’s analysis.

On appeal, Medtronic argued the PTAB had “committed a host of legal errors in its analysis of Teleflex’s objective evidence and the parties’ prima facie arguments”.

The Federal Circuit affirmed the PTAB’s ruling and concluded no errors were made, considering the evidence of nexus, copying and additional objective indicia.

The court found that the objective evidence presented by Teleflex was closely linked to the GuideLiner product, which constituted the invention disclosed in the patents. Therefore, the PTAB's determination of a nexus between the objective evidence and the side opening claims was upheld.

Another key component of case 21-2357 was Teleflex's claim of copying against Medtronic. The PTAB found “Medtronic copied the GuideLiner based on its findings that Medtronic had access to the GuideLiner while it was developing the Telescope and the products have substantially similar designs, and (2) there was “direct evidence” Teleflex had copied “at least a portion of the GuideLiner device.”

The Federal Circuit agreed with the PTAB's conclusion, holding that the goods' considerable similarity and proof of access to the GuideLiner showed copying.

In addition, Teleflex introduced in case: 21-2357, evidence of objective indicia of nonobviousness linked to its GuideLiner products, “which are undisputedly embodiments of the side opening claims”.

This included evidence that “the GuideLiner was commercially successful, solved long-felt but unsolved needs, garnered industry praise, and was copied by competitors, including Medtronic”.

The Federal Circuit upheld the PTAB's reliance on objective indicators of nonobviousness, which were crucial in the PTAB's conclusion.

One french claims

In case 21-2359 the Federal Circuit examined claim 48 of the '760 patent, the ‘one french claims’ (one french is a standard unit of measurement for catheter diameters), which involved a system consisting of a guide catheter and a guide extension catheter.

Medtronic contended that modifying a previous device, Ressemann, by eliminating sealing balloons and incorporating a prior approach (Takahashi) would render the claimed invention obvious.

Teleflex countered that such alterations would undermine Ressemann's intended purpose of providing embolic protection, rendering it unfit for advanced interventional devices.

The PTAB sided with Teleflex, highlighting that Ressemann's fundamental premise rested on the usage of sealing balloons, removing which would jeopardise the safety of these cutting-edge medical devices.

Agreeing with the PTAB's findings, the Federal Circuit emphasised that Medtronic failed to substantiate the obviousness of the one french claims.

Double-incline claims

In case 21-2359, Medtronic also challenged the double-incline claims in Teleflex’s '380 patent.

It argued that combining Kataishi's distal tip with Ressemann's proximal side opening would have been an obvious step.

However, the PTAB remained unpersuaded by Medtronic's arguments, noting the absence of motivation for skilled artisans to employ Kataishi's tip in Ressemann's opening.

The Federal Circuit agreed with the PTAB's stance, asserting that the conclusions were well-supported by substantial evidence and Medtronic failed to demonstrate the obviousness of the double-incline claims.

Substitute claims

The Federal Circuit addressed Teleflex's proposal of substitute claims for the '379 patent.

One of the substitute claims, claim 49, amended claim 38 and outlined a method of forming a device used with a guide catheter.

Medtronic questioned the adequacy of written description particularly that “the substitute claims encompass catheters with side openings physically separate from the substantially rigid portion, whereas the written description only describes side openings that were part of the substantially rigid portion”.

However, the PTAB concluded: “the substitute claims had adequate written description support and would not have been obvious over Medtronic’s asserted grounds”.

The Federal Circuit upheld the PTAB's decision, noting that the original specification provided enough detail, and the absence of specific embodiments did not hinder the written description.

With the Federal Circuit affirming the PTAB's decisions, Medtronic's appeals against the obviousness of the side-opening claims, the one french claims, and double-incline claims were dismissed.

Simultaneously, the PTAB's decision to grant the substitute claims was upheld.

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25 May 2023   Medtronic prior art reference does not qualify, says Federal Circuit | Firm was hoping to invalidate five catheter technology patents.