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25 May 2023MedtechLiz Hockley

Split Fed Cir refutes Medtronic challenge to catheter patents

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

Yesterday (May 24) a split US Court of Appeals for the Federal Circuit upheld five patents covering catheter technology held by Teleflex Innovations, quashing Medtronic’s bid to prove them invalid.

Two of the three CAFC judges—Chief Judge Kimberly Moore and Judge Alan Lourie—found that Medtronic’s primary prior art reference did not qualify as prior art, with Judge Timothy Dyk dissenting and arguing that it could support a determination of anticipation or obviousness.

The patents-in-suit, US patent numbers 8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379, were developed by Vascular Solutions (VSI) but now owned by Teleflex, and relate to technology in guide extension catheters that reduces the likelihood that a guide catheter will dislodge from a coronary artery’s opening.

Teleflex told the court that VSI conceived of the claimed invention in 2005 and developed it under the GuideLiner name, with a ‘rapid exchange’ or RX version practising the patents. At the same time, it developed an ‘over-the-wire’ or OTW version that did not use the patents and was more similar to existing products.

Medtronic filed 13 petitions for inter partes review of the challenged patents, with five being consolidated in this appeal. These petitions cited US Patent 7,736,355 (‘Itou’) as the primary prior art reference, which Teleflex argued did not qualify because the inventions were conceived before Itou’s filing date of September 23, 2005 (the ‘critical date’), and were actually reduced to practice before the critical date or diligently pursued until their constructive reduction to practice through their effective filing in May 2006.

The US Patent and Trademark Office (USPTO) concurred that the claimed inventions were conceived before the critical date, and “either actually reduced to practice for their intended purpose in April and July 2005, before the critical date, or diligently worked on toward constructive reduction to practice on May 3, 2006, the challenged patents’ effective filing date”.

Furthermore, the board found that the intended purpose of the inventions was providing improved backup support for the guide catheter, not backup support necessary for accessing and crossing tough or chronic occlusions as Medtronic claimed. It concluded that Itou did not qualify as prior art and that Medtronic had failed to show the challenged claims were unpatentable.

Medtronic challenged the USPTO’s findings on actual reduction to practice and reasonable diligence toward constructive reduction to practice.

The Federal Circuit dismissed the firm’s arguments on these points, disputing the medical device company’s claims that Teleflex’s evidence of actual reduction was insufficiently corroborated, and finding Medtronic’s proposed intended purpose to be overly narrow.

Contrasting viewpoint

Contrary to the majority, Judge Dyk found that Itou had been shown to be prior art to the patents at issue and therefore could support a determination of anticipation or obviousness.

He argued that under the pre-America Invents Act 35 U.S.C. § 102(e), Itou had an earlier filing date than that of the ‘032 patent, and that the evidence failed to adequately show that the RX GuideLiner had been reduced to practice before Itou’s filing date.

Dyk said that testimony from inventors during proceedings “never describes any specific tests showing the RX GuideLiner prototypes would work for their intended purpose of providing increased backup support or the results of the tests they did conduct”.

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