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New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

Addressing the issue of new claim constructions presented by a patent owner after the institution of inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found that a petitioner is entitled to argue and present evidence under the new construction so long as it relies on the same prior art embodiments used in the petition. Axonics, Inc. v. Medtronic, Inc., Case No. 22-1532 (Fed. Cir. Aug. 7, 2023) (Dyk, Lourie, and Taranto, JJ.)

Medtronic owns two patents directed to the transcutaneous charging of implanted medical devices via inductive coupling between a primary coil in an external charger and a secondary coil in the implanted device. The relevant claims of each patent require the external charger’s power to be automatically varied based on “a value associated with the current passing through the internal power source” (the value limitation) and “a measured current associated with the current passing through the internal power source” (the measured current limitation).

Axonics filed two IPR petitions challenging Medtronic’s patents, arguing that the claims were anticipated by three prior art references. Axonics’s petitions did not propose any express claim constructions, but its claim charts stated that the measured current limitation simply narrows the “value” in the value limitation to “measured current” and does not require a separate measurement. Under this “one-input” construction, both limitations would be satisfied if the external power source automatically varied its power output based on the implanted device’s current. In its preliminary response, Medtronic agreed that while claim construction was not necessary, the prior art failed to anticipate the claimed device under the one-input construction. In its institutional decision, the Patent Trial & Appeal Board agreed that “no term requires express construction.”

In its patent owner response, Medtronic (for the first time) advanced a new claim construction, arguing that the value limitation and the measured current limitation required separate inputs (the two-input construction). In Axonics’ reply, it defended the one-input construction and further argued that the three prior art references also disclosed the claimed device under the two-input construction. In support of its reply, Axonics submitted a supplemental expert declaration citing additional disclosures in the prior art references pertaining to the same embodiments relied upon in the petition. Medtronic argued that it would be prejudicial for the Board to consider Axonics’ new reply arguments without providing Medtronic an opportunity to submit a supplemental expert declaration. Medtronic, however, did not seek leave to submit a new declaration.

In its final written decision, the Board adopted the two-input construction and declined to consider Axonics’ arguments and evidence under the new construction, considering them to be improper reply arguments. Axonics appealed.

The Federal Circuit acknowledged that a petition is required to identify “in writing and with particularity…the grounds on which the challenge to each claim is based, and the evidence that supports the grounds.” To that end, a petitioner may not submit new evidence or arguments in a reply that could have been raised earlier but may respond to new arguments [...]

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Invoking Generic Need for Claim Construction Won’t Avoid § 101 Dismissal

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a patent infringement suit on § 101 grounds, rejecting the patentee’s argument that claim construction or discovery was required before assessing patent eligibility. Trinity Info Media, LLC v. Covalent, Inc., Case No. 22-1308 (Fed. Cir. July 14, 2023) (Stoll, Bryson, Cunningham, JJ.)

Trinity Info Media sued Covalent for infringement of patents related to poll-based networking systems that connect users in real time based on answers to polling questions. Covalent moved to dismiss, arguing that the patent claims were invalid under 35 U.S.C. § 101 because they were directed to patent-ineligible subject matter. In resolving the motion, the district court found that the claims were directed to the abstract idea of “matching users who gave corresponding answers to a question” and did not contain an inventive concept. The district court further found that the purported invention did not improve computer functionality but simply used “generic computer components as tools to perform the functions faster than a human would.” Accordingly, it found the asserted claims invalid under § 101 and granted the motion to dismiss. Trinity appealed.

Trinity argued that the district court erred by granting the motion without first allowing fact discovery and conducting claim construction. The Federal Circuit disagreed, finding that in order to overcome a motion to dismiss on § 101 grounds, “the patentee must propose a specific claim construction or identify specific facts that need development and explain why those circumstances must be resolved before the scope of the claims can be understood for § 101 purposes.” Trinity had identified claim terms to the district court, but never proffered any proposed constructions or explained how construction would affect the § 101 analysis. Because Trinity did not identify specific facts to be discovered or propose any particular claim construction that would alter the § 101 analysis, Trinity’s generic arguments were insufficient to avoid the motion to dismiss.

The Federal Circuit went on to analyze whether the asserted claims were invalid under the two-step framework established by Mayo and Alice. Under this framework, Step 1 evaluates whether the asserted claims are directed to a patent-ineligible concept, such as an abstract idea. Step 2 searches for an “inventive concept” by considering the claims to determine whether any elements “transform the nature of the claim” from ineligible subject matter into a patent-eligible application.

At Step 1, the Federal Circuit concluded that the claims were directed to the patent-ineligible abstract idea of “matching based on questioning.” The Court noted that a “telltale sign of abstraction is when the claimed functions are mental processes that can be performed in the human mind or using a pencil and paper” (citing Personal-Web), finding that the “human mind could review people’s answers to questions and identify matches based on those answers.” Further, the trivial variations appearing in some claims (e.g., using a handheld device, reviewing matches by swiping and matching based on gender) did not change the focus of the asserted claims. The Court explained that for software inventions, Step 1 [...]

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Amending a Range? Better Enable It

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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No Extra Life: Harmless Claim Construction Error Does Not Restart Invalidity Challenge

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision, finding that under the harmless error rule, the challenged claims were invalid as obvious even if the Board erred in claim construction. Bot M8 LLC v. Sony Interactive Entertainment LLC, Case Nos. 22-1291 (Fed. Cir. May 9, 2023) (ProstReyna, Cunningham, JJ.).

Bot M8 owns a patent related to a gaming machine that authenticates certain data and includes both a board and a motherboard. The independent claims require that a “game program” is stored in memory on the board and written to the motherboard only after the game program has been authenticated by a central processing unit (CPU) on the motherboard (the Write Limitation). Sony Interactive Entertainment petitioned for inter partes review (IPR). Ultimately, the Board determined that the challenged claims were unpatentable as obvious. Bot M8 appealed.

The issue presented to the Federal Circuit was what data the Write Limitation precludes from being written to the motherboard prior to authentication: (1) the entire game program, (2) any portion of the game program and/or (3) any data (including data not related to the game program). It was undisputed that the claims at minimum preclude writing the entire game program to the motherboard before authentication (option 1). Both the Board and the Court rejected Bot M8’s argument that would preclude writing any data whatsoever before authentication (option 3). The question thus resolved into whether the Write Limitation also precluded writing any portion of the game program prior to authentication (option 2). Bot M8 argued that it did.

Bot M8 focused on a statement made by the Board as indicative that the Board applied an erroneous claim construction that would allow a portion of the game program to be written prior to authentication (rejecting option 2): “[Bot M8] seeks to read into claim 1 a requirement that nothing related to, or any portion of, the gaming information be read into [the motherboard’s] RAM … prior to authenticating the game program.”

The Federal Circuit rejected Bot M8’s argument, finding that even if the Board erred in construing the claim, Bot M8 failed to demonstrate that the alleged error was harmful. Specifically, the Court found that any such error was harmless because the Board never needed to apply an improper construction since it found the prior art disclosed writing only non­­-game program data prior to authentication, a protocol that both the Board and the Court found was not precluded by the Write Limitation. Deeming the Board’s potential claim construction error harmless, the Court affirmed the Board’s invalidity determination.

Practice Note: Parties seeking to appeal a Board decision based on an improper claim construction theory should demonstrate how the Board’s error resulted in harm.




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Reaching New Lights: Inherent Upper Limit Enables Open-Ended Range

The US Court of Appeals for the Federal Circuit affirmed an International Trade Commission decision finding a § 337 violation. The Court concluded that the Commission correctly found that an open-ended claim was enabled since there was an inherent upper limit and correctly construed the term “a” to mean “one or more” in finding infringement. FS.com Inc. v. International Trade Commission, Case No. 22-1228 (Fed. Cir. Apr. 20, 2023) (Moore, Prost, Hughes, JJ.)

Corning Optical Communications owns several patents directed to fiber optic technology. Corning alleged that FS violated § 337 by importing high-density fiber optic equipment that infringed the patents. In assessing infringement, the Commission construed the claim term “a front opening” to mean “an opening located in the front side of a fiber optic module (e.g., the opening depicted in Figure 13 of the [asserted] patent as having dimensions H1 and W1”) and further concluded that the term encompassed one or more openings. The Commission found that FS’s products met this requirement and therefore infringed. FS argued that certain claims were invalid because they were not enabled. The claims at issue recited “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” or “a fiber optic connection of at least one hundred forty-four (144) fiber optic connections per U space.” FS argued that these open-ended density ranges were not enabled because the specification only enabled up to 144 fiber optic connections per U space. The Commission rejected FS’s invalidity argument. FS appealed.

The Federal Circuit affirmed the Commission’s enablement determination. The Court explained that open-ended claims are not inherently improper and may be enabled “if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.” The Court found that there was an inherent upper limit of about 144 connections per U space since skilled artisans would have understood that densities substantially above 144 connections per U space were technologically infeasible. The Court further found that the specification disclosed that the maximum density achievable was 144 connections per U space and expert testimony confirmed that, despite market pressure, no commercial product has achieved a density greater than 144 connections. Considering this evidence, the Court concluded that the Commission properly found that the open-ended claims had an inherent upper limit of about 144 connections per U space and the claimed open-ended range was therefore enabled.

The Federal Circuit also affirmed the Commission’s infringement determination. The Court explained that the terms “a” or “an” in a patent claim generally mean “one or more,” unless the patentee evinces a clear intent to limit “a” or “an” to “one.” FS argued that the recitation of “front openings” in an unasserted claim showed a clear intent to limit “a front opening” in the asserted claim to a single opening. The Court rejected that argument, finding that limiting an unasserted claim to multiple openings did not show an intent to limit the asserted claim to [...]

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Context Is Key in Claim Construction

The US Court of Appeals for the Federal Circuit reiterated that intrinsic evidence trumps extrinsic evidence in determining the meaning of claim terms. Sequoia Technology, LLC v. Dell, Inc. et al., Case Nos. 21-2263; -2264; -2265; -2266 (Fed. Cir. Apr. 12, 2023) (Stoll, Lourie, Dyk, JJ.)

Sequoia Technology owns a patent directed to data storage methods involving storing the same data across multiple physical disk drives to make up a virtual disk drive. Sequoia asserted the patent against several companies, all based on a product sold by Red Hat. During litigation, the parties disputed the construction of the terms “computer-readable recording medium,” “disk partition” and “logical volume.” Related to the latter two claim construction issues, the parties construed the term “used or not used” in the context of an extent’s usage in an “extent allocation table.”

The district court adopted Red Hat’s construction of “computer-readable recording medium” to include transitory media (i.e., signals or waves). The district court found no clear language in the specification that excluded transitory media and found Red Hat’s extrinsic evidence to be persuasive, “particularly given the lack of any substantive rebuttal from Sequoia’s expert.” For “disk partition” and “logical volume,” the district court agreed with Red Hat and construed “disk partition” to mean a “section of a disk that is a minimum unit of a logical volume” and “logical volume” to mean an “extensible union of more than one disk partition, the size of which is resized in disk partition units.” These constructions require that a logical volume is constructed by whole disk partitions, not subparts of disk partitions such as extents. The district court also construed the phrase “used or not used” in the limitation “extent allocation table for indicating whether each extent in the disk partition is used or not used,” adopting Red Hat’s construction that “used or not used” means that an extent “is or is not storing information.”

Following claim construction, the parties stipulated that under the district court’s claim construction of “logical volume” and “disk partition,” the accused products did not infringe the asserted claims. The parties also stipulated that under the district court’s construction of “computer-readable recording medium,” certain claims were subject matter ineligible under 35 U.S.C. § 101 as including transitory media. Sequoia appealed.

The Federal Circuit concluded that the district court erred in construing “computer-readable recording medium.” Starting with the claim language, the Court noted that the claim recited a “computer-readable recording medium storing instructions” and not simply a “computer-readable medium.” The Court reasoned that an ordinarily skilled artisan would understand transitory signals to be incompatible with the claimed invention because such fleeting signals would not persist for sufficient time to store instructions. Turning to the specification, the Court explained that although the specification did use open-ended “including” language to describe a computer-readable medium, the relevant portion of the specification defined computer-readable media as “including compact disc read only memory (CDROM), random access memory (RAM), floppy disk, hard disk, and magneto-optical disk,” all of which are non-transient [...]

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It’s All in the Grammar: “A” Still Means “One or More,” but Single Component Must Perform All Claimed Functions

The US Court of Appeals for the Federal Circuit affirmed a jury’s noninfringement verdict, finding that the district court correctly interpreted the article “a” and antecedent “said” in the asserted claims to require that a single microprocessor be capable of performing every one of the recited microprocessor functions. Salazar v. AT&T Mobility LLC et al., Case No. 21-2320; -2376 (Fed. Cir. Apr. 5, 2023) (Stoll, Schall, Stark, JJ.)

Joe Salazar owns a patent directed to technology for wireless and wired communication, including command, control and sensing systems for two-way communications. In 2016, Salazar sued HTC, alleging that HTC infringed the patent by selling certain phones that allegedly embodied the asserted claims. A jury returned a verdict finding that HTC did not infringe. In 2019, Salazar sued AT&T, Sprint, T-Mobile and Verizon (collectively, the Telecom Providers) asserting the same patent against the same HTC products. HTC intervened, arguing that the accused products did not infringe. The district court severed HTC and stayed that portion of the case.

At claim construction, the parties disputed limitations that required “a microprocessor for generating, . . . said microprocessor creating . . . , a plurality of parameter sets retrieved by said microprocessor . . . , [and] said microprocessor generating.” The essence of the dispute was “whether the claims require one microprocessor that is capable of performing the recited ‘generating,’ ‘creating,’ ‘retrieving,’ and ‘generating’ functions.” The district court answered the question in the affirmative and construed the term to mean “one or more microprocessors, at least one of which is configured to perform the generating, creating, retrieving, and generating functions.” The district court further reasoned that “at least one microprocessor must satisfy all the functional (and relational) limitations recited for ‘said microprocessor.’” At trial, the jury found that the accused products did not infringe and that the patent was not invalid. Salazar appealed, and the Telecom Providers cross-appealed.

Salazar argued that the district court erred in construing “a” microprocessor and “said” microprocessor and that the court should have interpreted the claim terms to require one or more microprocessors, any one of which may be capable of performing the “generating,” “creating” and “retrieving” functions recited in the claims. Put another way, in Salazar’s view, the correct claim construction would encompass one microprocessor capable of performing one claimed function and another microprocessor capable of performing a different claimed function, even if no single microprocessor could perform all of the recited functions.

The Federal Circuit rejected Salazar’s argument. Generally, the indefinite article “a” means “one or more” in open-ended claims containing the transitional phrase “comprising.” An exception to the general rule arises where the language of the claims themselves, the specification or the prosecution history necessitates a departure from the rule. The Court found that while the claim term “a microprocessor” does not require that there be only one microprocessor, the subsequent limitations referring to “said microprocessor” require that at least one microprocessor be capable of performing each of the claimed functions. The Court further explained that [...]

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No One Likes a Sore Winner: IPR Prevailing Party Can’t Appeal

Reaffirming precedent, the US Court of Appeals for the Federal Circuit reiterated the rule that the prevailing party in an inter partes review (IPR) cannot appeal a Patent Trial & Appeal Board decision. Termax Co. v. Illinois Tool Works, Inc., Case Nos. 23-1252; -1254 (Fed. Cir. Mar. 8, 2023) (Dyk, Reyna, Chen, JJ.)

Illinois Tool Works (ITW) asserted that Termax had infringed a patent directed to an automobile fastener. Termax challenged the asserted patent by filing a petition for IPR. The petition was granted, and ultimately the Board agreed with Termax that all the challenged claims of ITW were unpatentable. Both parties appealed.

ITW moved to voluntarily dismiss its own appeal and to dismiss Termax’s cross-appeal. Termax opposed, arguing that the Board erred in its construction of certain claim limitations that have also been incorporated into a new ITW patent.

The Federal Circuit dismissed both appeals. Citing what it called a “familiar rule,” the Court stated that the winner in a lower court or other tribunal cannot ordinarily seek relief in the appellate court. The Court was not persuaded by Termax’s argument that the Board erred in its construction of certain claim limitations, noting that Termax sought to appeal the constructions in the hopes that a Federal Circuit decision in its favor would “collaterally estop Illinois Tool Works from asserting those newly issued claims.” However, the Court refused to hear the appeal prematurely, stating that if ITW asserts the claims of its new patent against Termax in the future, Termax can address the issue at that time.

Practice Note: While an IPR can be a powerful tool for accused infringers, it is not without future risks.




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Transfer Motions Take Priority Regardless of Target District

The US Court of Appeals for the Federal Circuit granted a writ of mandamus and ordered the district court to decide a motion for intra-district transfer before proceeding to further substantive matters, explaining that both intra-district and inter-district transfer motions must be prioritized. In re: Apple Inc., Case No. 23-120 (Fed. Cir. Mar. 6, 2023) (per curiam) (nonprecedential).

SpaceTime3D sued Apple for patent infringement in February 2022 in the Western District of Texas, Waco Division. In July 2022, Apple moved to transfer the action within the Western District to Austin. The motion was fully briefed by the parties on November 7, 2022. The claim construction hearing was scheduled for November 17, 2022, based on an agreement between the parties. The day before the hearing, Apple moved to stay the hearing and all other proceedings until the district court ruled on Apple’s pending motion to transfer. The district court deferred claim construction, then denied Apple’s stay motion. The district court acknowledged that it was required to prioritize a motion for inter-district transfer but stated that “it does not have to stay the proceedings or decide whether to transfer the case intra-district until closer to trial.” Apple filed a writ of mandamus with the Federal Circuit.

The Federal Circuit noted that although the remedy of mandamus is drastic and should be invoked only in extraordinary situations, it has previously granted mandamus “to correct a clearly arbitrary refusal to act on a longstanding pending transfer motion.” The Federal Circuit stated that under Fifth Circuit law, precedent entitles parties to have their transfer motions prioritized. The Federal Circuit was not swayed by the trial court’s reliance on a statement in an unpublished, nonprecedential Fifth Circuit decision in Sundell v. Cisco Systems, Inc., because the Fifth Circuit did not suggest any discretion in the prioritization of transfer motions based on the type of transfer. The Federal Circuit explained that the Fifth Circuit does not require that inter-district transfer motions be prioritized to the exclusion of intra-district transfer motions. The Federal Circuit granted Apple’s petition for mandamus and ordered the district court to timely decide the transfer motion before proceeding with further substantive matters beyond the claim construction hearing.




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Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method of use. Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Case No. 23-1186 (Fed. Cir. Feb. 24, 2023) (Lourie, Reyna, Taranto, JJ.)

Jazz Pharmaceuticals holds a new drug application (NDA) for Xyrem, an oral sodium oxybate solution prescribed to help those with certain narcolepsies manage cataplexy. Sodium oxybate itself is no longer covered by patents because it has been used in relation to narcolepsy since the 1960s. For this reason, Jazz built its patent portfolio around Xyrem’s formulation, use and distribution.

Jazz uses a single-pharmacy distribution system for Xyrem, known as a risk evaluation mitigation strategy (REMS). Implementing REMS was a condition of Xyrem’s US Food & Drug Administration (FDA) approval because it mitigates safety risks of dangerous active pharmaceutical ingredients such as sodium oxybate. One of Jazz’s patents is directed to this REMS distribution system. Abbreviated New Drug Application (ANDA) 505(b)(2) NDA (Hybrid NDA) approval is similarly conditioned on implementing a REMS that is sufficiently comparable to any that the NDA holder must implement. The FDA eventually determined that single-pharmacy systems were unnecessary for Xyrem and potentially detrimental.

Avadel submitted a hybrid NDA for a drug that requires only a single nightly dose, unlike Xyrem, which requires a patient to wake up during the night to ingest a second dose. Avadel’s application also proposed a more lenient REMS that utilizes multiple pharmacies. In view of these differences, Avadel believed that it could avoid a lengthy FDA approval process because all of Jazz’s Xyrem Orange-Book-listed patents seemed addressable without making any Paragraph IV certifications. As for the REMS patent, Avadel filed a statement under 21 U.S.C. § 355(b)(2)(B) because the patent was listed as claiming a method of use and Avadel was not seeking approval for the REMS system to which that patent’s claims were directed.

Jazz sued Avadel asserting seven patents, of which the REMS patent was the only Orange-Book-listed patent. Avadel asserted a counterclaim requesting that the district court order Jazz to delist the REMS patent from the Orange Book. The district court subsequently held a Markman hearing finding that the REMS patent’s claims were directed to a system and not a method. The district court granted Avadel’s motion for judgment on the pleadings, finding that the REMS patent did not claim “the drug for which the application was approved” and thus had to be delisted from the Orange Book. Jazz appealed.

Jazz argued that because the FDA permitted the REMS patent to be Orange Book listed, Avadel was prohibited from availing itself of the statutory delisting provision. The Federal Circuit disagreed, concluding that the language of the delisting provision was only concerned with whether a listed patent met the provisions’ conditions at the time of the triggering litigation.

Jazz also argued that there was no evidence that Congress imported patent-law [...]

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