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Federal Circuit

Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

by Kavya Rallabhandi | Jul 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.

Federal Circuit to Revisit Whether KSR Extends to Design Patents

by Courtney Seams | Jul 13, 2023 | Patents

Granting a petition for rehearing en banc, the US Court of Appeals for the Federal Circuit decided to revisit the effect of the Supreme Court’s 2007 decision in KSR International v. Teleflex on design patents. LKQ Corporation v. GM Global Technology Operations, Case No. 21-2348 (Fed. Cir. June 30, 2023) (per curiam). The Federal Circuit withdrew its earlier panel decision addressing KSR’s application to design patents.

This case arose from an inter partes review (IPR) filed by LKQ against GM alleging that GM’s design patent for a vehicle fender was obvious and/or anticipated. In its original opinion, the Federal Circuit applied its predecessor court’s design patent test for obviousness in In re Rosen (CCPA 1982), as well as its decision in Durling v. Spectrum Furniture (Fed. Cir. 1996), ultimately finding that GM’s design patent was not obvious or anticipated and affirming the Patent Trial & Appeal Board’s decision. The Federal Circuit determined that it was unclear whether the Supreme Court had overruled Durling and Rosen with KSR, so it did not apply KSR. Judge Lourie provided an additional opinion that KSR did not overrule Rosen. Judge Stark concurred in the judgment but found that LKQ had forfeited its argument that KSR overruled Rosen.

In its order for en banc review, the Federal Circuit asked the parties to address whether KSR abrogates Rosen and Durling and whether KSR applies to design patents regardless of whether it overrules or abrogates Rosen and Durling. Specifically, the Court inquired whether KSR’s “expansive and flexible approach” means that Durling’s two requirements should be modified or eliminated. Durling’s first requirement is that “[b]efore one can begin to combine prior art designs . . . one must find a single reference, ‘a something in existence, the design characteristics of which are basically the same as the claimed design.’” Its second requirement is that secondary references “may only be used to modify the primary reference if they are ‘so related to the primary reference that the appearance of certain ornamental features in one would suggest the application of those features to the other.’”

The Federal Circuit also asked the parties to address the appropriate test for evaluating the obviousness of design patents in the event the Rosen-Durling test was to be eliminated or modified.

The Federal Circuit further requested that the parties address whether eliminating the Rosen-Durling test would cause uncertainty in a settled area of law. Finally, the Court asked whether any differences between design patents and utility patents are relevant to the design patent obviousness inquiry.

The Federal Circuit indicated that the issues of anticipation and forfeiture from the initial appeal were preserved, but that additional briefing on those issues was not required. The Court invited the United States to participate as amicus curiae.

Practice Note: With the Federal Circuit granting rehearing en banc, there is a possibility that the Court may extend the obviousness analysis of KSR to design patents.

Amending a Range? Better Enable It

by Alexander Piala, PhD | Jul 13, 2023 | Patents

In a post-grant review appeal, the US Court of Appeals for the Federal Circuit explained that patent claims reciting a range must enable the full scope of that range and, under the Administrative Procedure Act (APA), the Patent Trial & Appeal Board is not bound to decisions rendered in a Preliminary Guidance. Medytox, Inc. v. Galderma S.A., Case No. 22-1165 (Fed. Cir. June 27, 2023) (Dyk, Reyna, Stark, JJ.)

Medytox owns a patent directed to the use of animal-protein-free botulinum toxins with long-lasting effects. Galderma challenged the validity of Medytox’s patent in a post-grant review. In response to the challenge, Medytox filed a motion to amend the patent under the Board’s Pilot Program, which allows a petitioner to amend the patent claims and receive a preliminary decision as to whether the amendment would preserve the patent’s validity (Preliminary Guidance). Medytox proposed modifying the claims so that they only encompassed treatment methods that possessed a patient response rate of “50% or greater.” Galderma opposed the motion, arguing that claiming a 50% to 100% response rate constituted new matter, meaning the claim language improperly claimed an invention that was not described in the patent application as filed.

The Board issued a Preliminary Guidance construing the new claim language and explaining that it did not believe that Medytox’s amended claims represented new matter. According to the Board, the new limitation did not “necessarily” claim a range of 50% to 100% and instead could just be claiming 50% or greater. The Board explained that since the patent contained the concept of a greater than 50% response rate, claiming that rate was not new matter. As a consequence of the Board’s positive reception, Medytox amended all the claims to include the new language. Galderma once again opposed the motion and further argued that the amended claims were not enabled. The Board held an oral hearing and questioned the parties on the proper construction of the “50% or greater” claim language.

In its final written decision, the Board decided that the limitation was a range of 50% to 100%, contrary to its statement in the Preliminary Guidance. Because the claimed limitation was a range, the Board—citing the Supreme Court’s 2023 decision in Amgen v. Sanofi and the Federal Circuit’s 2012 decision in Magsil v. Hitachi Global Storage—explained that the entire range must be enabled. The patent, however, only described a response rate of up to 62%, so the Board found that the claimed range was not enabled. Medytox appealed.

Medytox alleged three errors. First, Medytox argued that the Board’s new construction was wrong. Second, Medytox argued that the claims were enabled. Finally, Medytox argued that the Board violated the APA by capriciously departing from its Preliminary Guidance. The Federal Circuit rejected Medytox’s arguments and affirmed the Board’s decision.

First, the Federal Circuit determined that there was no meaningful difference between the two possible constructions—claiming a response rate greater than 50% was essentially the same as claiming a response rate of [...]

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If at First You DuPont Succeed, Try a Different Factor

by Mike Baldwin | Jul 13, 2023 | Trademarks

The US Court of Appeals for the Federal Circuit remanded a Trademark Trial & Appeal Board decision, finding that the Board incorrectly analyzed several DuPont factors, improperly disregarded the DuPont factor regarding third-party registration on similar goods, permitted the opposer to succeed without a showing of identical marks for identical goods used in the marketplace and predicated its comparative analysis on the incorrect mark. Spireon, Inc. v. Flex Ltd., Case No. 22-1578 (Fed. Cir. June 26, 2023) (Mayer, Reyna, Dyk, JJ.)

Spireon filed a trademark application for the mark FL FLEX for use in connection with “[e]lectronic devices for tracking the locations of mobile assets in the nature of trailers, cargo containers, and transportation equipment using global positioning systems and cellular communication networks.” After the Examining Attorney approved the application, Flex opposed registration on grounds of priority and likelihood of confusion with Flex’s previously registered marks: FLEX, FLEX (stylized) and FLEX PULSE.

The Board sustained Flex’s opposition based on its analysis of the DuPont factors for evaluating likelihood of confusion. There are a total of 13 factors that together form the underlying factual findings upon which the legal conclusion of likelihood of confusion is made. Not all factors are relevant in every case.

In its consideration of the first DuPont factor (the similarity of the marks), the Board addressed the strength of Flex’s marks, including the marks’ conceptual and commercial strength. The Board weighed five marks—FLEX (in three relevant commercial contexts), LOAD FLEX VALUE FLEX—and concluded that the third-party evidence did not show that Flex’s marks were either conceptually weak or inherently distinctive. The Board then considered the similarity of the marks, analyzing Spireon’s FL FLEX against FLEX, FLEX (stylized) and FLEX PLUS (rather than the actual mark FLEX PULSE). The Board found the marks highly similar and concluded that the first DuPont factor supported a finding of likelihood of confusion. The Board also addressed three other DuPont factors that it considered relevant, but no others. Spireon appealed.

The Federal Circuit reversed. The Court found that the Board erred in not considering the sixth DuPont factor, “[t]he number and nature of similar marks in use on similar goods.” This factor requires an evaluation of conceptual strength and commercial strength. Conceptual strength focuses on the degree to which a mark is descriptive in that it “directly and immediately convey[s] some knowledge of the characteristics of products.” Commercial strength focuses on the “marketplace recognition value of the mark.”

The Federal Circuit explained the relevance of third-party registrations and their bearing on a mark’s conceptual strength, noting that the Board erred in assigning a low probative value to 15 composite marks of record. The Court explained that composite third-party marks are relevant to resolving the question of whether the “shared segment—in this case, ‘flex’—has a commonly understood” meaning in the pertinent field and to the crowded nature of the field in which the flex root is used. As the Court explained, proof of use or non-use is material because the sixth DuPont factor only considers [...]

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Not on the Merits: Claim Preclusion Doesn’t Bar Inducement Claims After Direct Infringement Case

by Hannah Cohen | Jul 13, 2023 | Patents

Applying Seventh Circuit law to determine whether the dismissal of patent infringement claims should be upheld on the basis of claim preclusion, the US Court of Appeals for the Federal Circuit reversed a district court ruling that the claims were precluded by res judicata. Inguran, LLC v. ABS Global, Inc., Case No. 22-1385 (Fed. Cir. July 5, 2023) (Lourie, Bryson, Reyna, JJ.)

At the district court, ABS argued that a previous infringement suit brought by Inguran precluded it from bringing the instant suit. At issue was whether the previous suit asserting direct infringement of Inguran’s “GSS technology” used to create “single-sexed semen straws” barred the current suit, which alleged that ABS induced third parties to infringe upon the same technology by entering into licensing agreements with these third parties. The district court agreed with ABS. Inguran appealed.

To successfully assert claim preclusion under Seventh Circuit law, a party must meet the following three-factor test:

An identity of the parties or their privies in the first and second lawsuits
An identity of the cause of action
A final judgment on the merits in the first suit.

The Federal Circuit’s analysis focused on the second requirement. In determining whether there was an identity of the cause of action, the Court examined whether the second claim was based on the same set of transactional facts as the earlier litigation between the parties. In patent infringement cases, the general rule is that res judicata does not bar the assertion of new rights acquired during the previous action, which could have been litigated but were not (i.e., claims that arose while the litigation was ongoing but after the original complaint was filed).

The Federal Circuit determined that the transactional facts between the present case and the previous litigation were different because the cases respectively centered around theories of induced infringement by third parties and direct infringement. As the Court noted, “The evidence needed to support these two claims (induced infringement vs direct infringement) is different.” To allege and prove induced infringement, Inguran needed to establish additional facts beyond what it asserted in the previous case to show direct infringement. As the Court noted, an “induced infringement claim rests on evidence and elements beyond those required by direct infringement.” Although minimal evidence regarding the activities of the third parties was part of the record in the previous litigation, the parties ultimately stipulated that direct infringement occurred. The issue of induced infringement, however, was never presented to the jury.

The Federal Circuit held that although both cases implicated similar facts, including extensive discussions of the “GSS technology,” the direct infringement allegations could not reasonably serve to bar later allegations regarding the actions of third-party licensees. The Court accepted Inguran’s argument that any induced patent infringement claim it might have brought at the time of the earlier case would have been based on speculation: “[w]e agree with ST that it could not have asserted an inducement claim during ABS I.” The Court therefore rejected the district [...]

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First Rule of the PTAB? Play by the Rules

by Christian Tatum | Jun 22, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed two Patent Trial & Appeal Board decisions holding the challenged claims unpatentable as obvious, even though the Board declined to consider evidence of antedating and found that the claims lacked written description support. Parus Holdings, Inc. v. Google LLC, Case Nos. 22-1269; -1270 (Fed. Cir. June 12, 2023) (Lourie, Bryson, Reyna, JJ.)

Parus Holdings owns two patents related to an interactive voice system to request information from a voice web browser. Google (among others) petitioned for inter partes review (IPR) of the patents.

During the IPR proceedings, the Board found that a publication (Kovatch) was prior art to the challenged patents. In reaching that decision, the Board declined to consider Parus’s arguments and evidence of an earlier conception and reduction to practice because they were only presented via incorporation by reference in violation of 37 C.F.R. § 42.6(a)(3). The Board ruled that Parus failed to meet its burden of production on antedating.

The Board also found that the publication of the application to which Parus’s challenged patents claimed priority (Kurganov-262) was prior art because the common specification failed to provide written description support for the challenged claims. Parus appealed the Board’s decision, raising two main arguments.

First, Parus contended that the Board erred when it declined to consider Parus’s arguments and evidence on antedating. Parus argued that § 42.6(a)(3)’s prohibition on incorporation by reference did not warrant the Board’s decision because Parus, as patent owner, need not have submitted a response at all. Parus also argued that the Federal Circuit’s 2017 decision in Aqua Products mandates that the Board consider all record evidence, regardless of the manner of presentation. The Federal Circuit rejected Parus’s arguments in turn.

Regarding Parus’s violation of the incorporation by reference rule, the Federal Circuit explained that Parus had assumed an affirmative burden of production when it chose to submit a response to antedate Kovatch. Along with that burden came other responsibilities, such as complying with the US Patent & Trademark Office’s (PTO) rules and regulations, including § 42.6(a)(3). The Court further explained that this burden of production could not be met without some combination of citing evidence with specificity and explaining the significance of the cited material. Parus did neither.

The Federal Circuit also rejected Parus’s argument that the Board is required by law to review all evidence in the record. The Court clarified that, while its Aqua Products holding requires the Board to decide all issues properly before it, nothing in Aqua Products requires the Board to review evidence or issues not introduced or introduced in violation of the Board’s rules. As the Court noted, “[t]he burden of production cannot be met simply by throwing mountains of evidence at the Board without explanation or identification of the relevant portions of that evidence. One cannot reasonably expect the Board to sift through hundreds of documents, thousands of pages, to find the relevant facts.”

Parus also argued that the Board exceeded its statutory authority under 35 U.S.C. [...]

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Under High Pressure: New Mechanism of Action Can’t Save Drug Administration Claims

by Katherine Pappas | Jun 22, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board ruling that method claims reciting a mechanism of action triggered by the co-administration of two known antihypertensive agents were obvious over the cited prior art. In re Couvaras, Case No. 22-1489 (Fed. Cir. June 14, 2023) (Lourie, Dyk, Stoll, JJ.)

This case arose out of applicant John Couvaras’s prosecution of patent claims reciting a method of increasing prostacyclin release in the systemic blood vessels to improve vasodilation in a human with essential hypertension by co-administering two therapeutic agents. During prosecution, Couvaras conceded that the two claimed therapeutic agents had been known as essential hypertension treatments for many decades. The examiner agreed, citing 10 references as confirmation. The examiner further found that the physiological results of co-administering the two therapeutic agents were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.

Couvaras appealed to the Board, arguing that the increased prostacyclin release was unexpected and that objective indicia overcame any existing prima facie case of obviousness. The Board disagreed, ruling that the increased prostacyclin release was inherent in the obvious administration of the two known antihypertensive agents and that no evidence existed to support a finding of any objective indicia. Couvaras appealed.

Couvaras raised three arguments on appeal:

The Board erred in affirming that a skilled artisan would have had motivation to combine the art.
The claimed mechanism of action was unexpected, and the Board erred in discounting its patentable weight by deeming it inherent in the claimed method.
The Board erred in weighing objective indicia of non-obviousness.

With respect to motivation to combine, the Federal Circuit agreed with the Board that the art supplied sufficient motivation to combine because the claimed therapeutic agents were known for decades to treat hypertension, finding the Board’s conclusion supported by substantial evidence. The Court found that Couvaras had forfeited a related argument for no reasonable expectation of success by failing to first raise that challenge to the Board.

The Federal Circuit also rejected Couvaras’s argument that the claimed mechanism of action was unexpected and therefore entitled to patentable weight. Couvaras argued that the Board downgraded the patentable weight of limitations drawn to the antihypertensive agents’ mechanism of action by deeming them to be merely inherent. According to Couvaras, even if the recited mechanism of action was inherent in the claimed administration of the two agents, that mechanism was unexpected because the increased prostacyclin release was unexpected and could not be dismissed as having no patentable weight due to inherency.

The Federal Circuit disagreed, explaining that Couvaras was attempting to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents and that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” The Court allowed that while mechanisms of action may not always meet the most rigid standards for inherency, “[r]eciting the mechanism for known compounds [...]

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Inventorship Hosed Clean: Contribution, Corroboration and Collaboration Prove Joint Invention

by James M. Oehler | Jun 22, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a decision to correct inventorship, finding that the alleged joint inventor’s contribution to a claimed invention was significant and adequately corroborated by evidence. Blue Gentian, LLC v. Tristar Products, Inc., Case Nos. 21-2316; -2317 (Fed. Cir. June 9, 2023) (Prost, Chen, Stark, JJ.)

Blue Gentian owns utility and design patents directed to an expandable hose. Prior to filing the first patent application, Michael Berardi (the sole inventor of the asserted patents and Blue Gentian’s principal) met with non-party Gary Ragner to discuss investing in Ragner’s expandable hose. Berardi had no experience designing hoses at the time of the meeting. Berardi testified that he came up with the idea of his hose after watching a demonstration video of Ragner’s hose but before the meeting. At the meeting, Ragner disclosed a prototype and documents relating to his hose and discussed the inner components of the hose. Berardi built his first prototype a day after the meeting and filed his first patent application three months later. Blue Gentian subsequently filed suit against Tristar for infringement of its expandable hose patents. Tristar counterclaimed to correct inventorship of the patents, alleging that Ragner should have been named a co-inventor.

A court may order a correction of inventorship when it determines that an inventor has been erroneously omitted from a patent. The inventors listed on an issued patent, however, are presumed to be the only true inventors. Thus, a party must prove incorrect inventorship by clear and convincing evidence. An alleged joint inventor’s testimony standing alone is insufficient to establish inventorship by clear and convincing evidence; the testimony must be corroborated by evidence. A joint inventor must contribute significantly to the invention’s conception or reduction to practice, and the contribution must involve some collaboration with the other inventor.

The district court, after an evidentiary hearing, entered judgment on the inventorship counterclaim in Tristar’s favor and ordered correction of the patents under 35 U.S.C. § 256. Blue Gentian appealed.

The Federal Circuit found that Ragner conveyed three key elements of the hose to Berardi at the meeting and that these elements were a significant contribution to the conception of at least one claim of each asserted patent. The Court noted that these were the very elements Blue Gentian used to distinguish the invention from the prior art, establishing the element’s significance. The Court also found that Ragner’s testimony about conveying the three elements to Berardi at the meeting was adequately corroborated by both physical and circumstantial evidence. The evidence showed the similarity between Ragner’s disclosed prototype and Berardi’s first prototype, and documentary evidence showed Ragner’s familiarity with the three elements before the meeting. Finally, the Court found sufficient collaboration between Berardi and Ragner based on the information exchanged at the meeting, including Ragner’s prototype, confidential documents and verbal explanations about alternative hose designs.

The Federal Circuit dismissed Blue Gentian’s argument that claim construction was needed before analyzing Ragner’s contribution because Blue Gentian did not identify a dispute [...]

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Absent Nexus Secondary Considerations Come in Second

by Courtney Seams and Gaylon C. Hollis | Jun 15, 2023 | Patents

Addressing the nexus between a secondary consideration and the claimed invention in assessing obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board finding of nonobviousness because the Board erred in its nexus analysis regarding secondary considerations. Yita LLC v. MacNeil IP LLC, Case Nos. 22-1373; -1374 (Fed. Cir. June 6, 2023) (Taranto, Chen, Stoll, JJ.)

Yita petitioned for inter partes review (IPR) of all claims of two patents. The patents share a common specification and cover vehicle floor trays that are theraformed from a polymer sheet of substantially uniform thickness. These trays (illustrated below) were designed to closely conform to the walls of the vehicle foot well so that the trays would stay in place once installed.

The Board found that the claims of one of the patents were not obvious even though an artisan would have been motivated to combine the prior art asserted (which disclosed the “close conformance” limitation) and would have had a reasonable expectation of success because the evidence of secondary considerations was overpowering and included a nexus between the evidence of success and the patented invention. The Board also found that the claims of the other patent were not obvious because the “1/8 inch limitation” regarding the thickness of the foot well was not disclosed in the prior art. The Board declined to consider Yita’s argument, which was raised for the first time in its reply brief. Yita appealed.

Yita argued that the Board committed a legal error in its analysis of the secondary consideration evidence for the first patent and abused its discretion by not considering the argument Yita raised in its reply brief regarding the other patent.

On the secondary considerations issue, the Federal Circuit explained that the Board erred in finding a nexus between the secondary consideration evidence of success and the claimed invention because the Board exclusively related to a feature that was well-known in the prior art (i.e., the close conformance between the tray and the vehicle floor). The Court explained that where the prior art teaches a well-known feature and an artisan would have been motivated to combine such prior art with an expectation of success, any secondary consideration that is exclusively related to the well-known feature will not rescue the claim from obviousness. The Court noted that while secondary considerations can be linked to an individual element of the claimed invention or to an inventive combination of elements, here the Board relied on secondary consideration evidence that was related entirely to the already well-known close conformance of the tray and vehicle floor.

The Federal Circuit next addressed Yita’s argument that the Board should have considered an argument raised in Yita’s reply brief regarding the 1/8-inch limitation. Yita failed to raise the argument that it would have been obvious to modify a prior art reference to arrive at the “1/8 inch limitation” [...]

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Obviously Prima Facie Case Overcome by Secondary Considerations

by Benjamin Ediger, Ph.D. | Jun 15, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board, holding that the Board did not err in finding certain challenged claims nonobvious and not unpatentable based on a showing of several objective criteria of nonobviousness and a nexus of the evidence to a commercial product embodying the claimed invention. Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2357 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.) and Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2359 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.)

Teleflex developed and patented a novel catheter-based stenosis intervention system that successfully mitigated long-standing risks intrinsic to existing catheter-based intervention systems, in particular damage to the coronary artery from guide catheter dislodgement or a catheter’s distal tip (i.e., the end of the catheter farthest from the insertion site). The preferred embodiments incorporated into Teleflex’s extremely successful GuideLiner products comprised a proximal substantially rigid portion (yellow), a reinforced portion (blue) and a distal flexible tip (pink), as illustrated below.

The catheters were sized so they could be inserted through standard guide catheters and thus were coined guide extension catheters. This innovative nesting feature increased guide catheter backup support while the guide extension catheter’s soft distal end was less likely to cause tissue damage once deeply inserted into patients. Teleflex’s guide extension catheters also were optimized for receiving interventional cardiological devices. This optimized function was a combination of the catheter’s coaxial lumen, that lumen’s diameter being no more than one French (i.e., 1/3 mm) less than the diameter of the guide catheter, and a proximal side opening that featured a double incline design like that illustrated above.

Teleflex’s GuideLiner was introduced in 2009 and enjoyed “undisputed commercial success and industry praise.” In 2019, Medtronic introduced its competing guide extension catheter (Telescope) and filed six inter partes review (IPR) petitions against Teleflex’s extension guide catheter family. Three of Medtronic’s petitions asserted that the challenged claims in three of Teleflex’s patents were obvious over the evacuation sheath assembly with a distal side opening used to aspirate embolic material while occluding blood flow using sealing balloons disclosed in a prior art reference (Ressemann). The other three petitions challenged claims of the other Teleflex patents as being obvious over a support catheter for delivering angioplasty balloons disclosed in a prior art reference (Kontos).

Medtronic specifically asserted that the following three elements of Teleflex’s claimed catheters were obvious:

A proximal side opening. Medtronic argued that it would have been obvious to replace the proximal funnel structure of Kontos’s support catheter with the distal side opening of Ressemann’s evacuation sheath assembly.
A catheter diameter that is no more than one French less than a corresponding guide catheter. Medtronic argued that in view of prior art mother-and-child dual catheter systems in which the child catheter’s diameter is no more [...]

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