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Chromatographic Clash: When Is a Lead Compound Analysis Even Necessary?

by | Dec 12, 2024 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s determination that 79 challenged composition claims across three related patents were unpatentable but reversed the Board’s determination that four challenged process claims were not unpatentable. Cytiva Bioprocess R&D v. JSR Corp., et al., Case Nos. 23-2074; -2075; -2191; -2192; -2193; -2194; -2239; -2252; -2253; -2255 (Fed. Cir. Dec. 4, 2024) (Prost, Taranto, Hughes, JJ.)

The patents in question pertain to chromatography matrices used in affinity chromatography for isolating antibodies. Their primary focus was on the G29A mutation in SPA IgG binding domains, which enhances stability in alkaline environments. The Board upheld the patentability of the process claims while invalidating the composition claims. Cytiva appealed, arguing that the Board erred in its lead compound analysis. JSR cross-appealed on the Board’s finding that the challenged process claim were not unpatentable.

The Federal Circuit disagreed with Cytiva’s argument that a lead compound analysis was necessary. A lead compound analysis is an obviousness framework that involves a two-part inquiry: whether a skilled person in the art would have selected the compound as a starting point for research, and whether the prior art would have motivated the skilled person to modify the compound into the claimed invention. The Federal Circuit noted that lead compound analyses are not always required in chemical patent cases where the prior art references expressly suggest the proposed modification, which was the case here. The Court also explained that even though a lead compound analysis was used here, in this case the claimed compounds could all be lead compounds, and the prior art expressly suggested the G29A modification of the claimed compound.

The Federal Circuit also addressed whether a claim limitation that merely recites an inherent property of an otherwise obvious combination requires additional analysis to demonstrate that a person of ordinary skill in the art would have a reasonable expectation of success. The Court found that additional analysis was unnecessary because “the sole disputed limitation was an inherent property of the claimed composition already determined to be obvious.” The Court found that the Fab binding property of the chromatography matrices was inherent and thus did not require a separate reasonable expectation of success analysis.

As for the process claims that the Board found not unpatentable, the Federal Circuit determined that the composition and process claims were “nearly identical and contain[ed] no substantive distinction relevant to th[e] appeal.” Therefore, the Court held that the Board erred in separating the composition and process claims and found “no basis for treating the claims differently.” The Federal Circuit reversed the Board’s “not unpatentable” determination on those claims and held all challenged patent claims obvious and therefore unpatentable.



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PTO Withdraws Proposed Rule on Terminal Disclaimer Changes

by | Dec 12, 2024 |

The US Patent & Trademark Office (PTO) withdrew its proposed rule that suggested major changes to its terminal disclaimer practice. 89 Fed. Reg. 96152 (Dec. 4, 2024).

In May 2024, the PTO issued a Notice of Proposed Rulemaking that would have required a terminal disclaimer to include an agreement that a patent would be unenforceable if it was tied directly or indirectly to another patent having any claim invalidated or cancelled based on prior art. During the proposed rule’s 60-day comment period, the PTO received more than 300 comments from a variety of stakeholders that both supported and opposed the proposal.

The PTO issued a notice withdrawing the proposal, explaining that in light of resource constraints, it decided not to move forward.



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Plausible Alternative Understanding of Prior Art? So What?

by | Dec 12, 2024 |

Affirming the Patent Trial & Appeal Board’s final determination that three claims were invalid for obviousness, the US Court of Appeals for the Federal Circuit ruled that a “plausible alternative understanding” of the prior art did not compel a reversal under the substantial evidence review standard. Koninklijke KPN N.V. v. Vidal, Case No. 19-2447 (Fed. Cir. Dec. 2, 2024) (Prost, Reyna, Chen, JJ.)

Three computer networking companies filed a petition for inter partes review (IPR) to challenge the patentability of claims of a patent for regulating access to a telecommunications network owned by Koninklijke. The challenged claims included limitations concerning devices, identified by a controller with a unique identifier, that requested access to a network. The controller allowed each device network access based on a “grant access time interval.” The petitioners argued that the challenged claims were unpatentable as obvious in view of three prior art references: Obhan, Shatzkamer, and Budka.

After considering the parties’ argument over what was disclosed by the references, the Board found that Obhan disclosed an admission control system for a wireless network that included assigning devices a “good till time.” The Board found that Shatzkamer disclosed managing a wireless network using a system to identify specific devices, add those devices to a “blacklist,” and deny network access to the blacklisted devices. The Board determined that the combination of Obhan, Shatzkamer, and Budka taught the limitations of the challenged claims. Koninklijke appealed.

Koninklijke argued that the Board erred in its determination that the prior art references taught certain claim limitations and provided motivation to combine the references.

Koninklijke first argued that substantial evidence did not support the Board’s finding that Obhan disclosed the access request limitations of the challenged claims. Koninklijke also argued that Obhan did not teach consulting a “good till time” to determine whether to allow a device to access the network. The Federal Circuit disagreed, finding that Koninklijke’s argument merely presented “a plausible alternative understanding of Obhan.” The Court explained that under the substantial evidence standard of review, this was not enough to conclude that the Board’s decision was unsupported by substantial evidence. The Court declined to reweigh the evidence or make factual findings of its own.

Second, Koninklijke argued that the Board’s determination was not supported by substantial evidence because the Board misread and misstated one of the challenged claims. An exemplary claim of the challenged patents recited “an access operation to deny access for the terminal if the access request is received within the time period,” whereas another recited “denying the terminal access to the telecommunications network responsive to the access request being received within the time period defined by the accessed identification of at least one associated deny access time interval.” In its decision, the Board stated that second claim “requires only that the access request be denied if it is received within the time period during which access is denied.” Koninklijke faulted the Board for using the term “if” instead of “responsive to.”

The Federal Circuit did not find [...]

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New Year, New Fees: PTO Issues 2025 Fee Schedule

by | Dec 5, 2024 |

The US Patent & Trademark Office (PTO) issued its final rule setting and adjusting patent fees that will take effect on January 19, 2025. 89 Fed. Reg. 91898 (Nov. 20, 2024).

The final rule sets or adjusts 433 patent fees for undiscounted, small, and micro entities, including the introduction of 52 new fees. The fee adjustments are grouped into three categories:

  • Across-the-board adjustment to patent fees.
  • Adjustment to front-end fees.
  • Targeted fees.

Fees not covered by the targeted adjustments will increase by approximately 7.5%. Front-end fees to obtain a patent (i.e., filing, search, examination, and issue fees) are set to increase by an additional 2.5% on top of the 7.5% across-the-board adjustment. Targeted adjustments include increasing fees related to continuing applications, design patent applications, filing excess claims, extensions of time for provisional applications, information disclosure statement sizes, patent term adjustments, patent term extensions, requests for continued examinations, suspension of actions, terminal disclaimers, unintentional delay petitions, and Requests for Director Review of a Patent Trial & Appeal Board decision.

More information, including the new fee schedule, is available on the PTO’s website.



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A Lesson in Judicial Principles: No Dismissal After Decision

by | Dec 5, 2024 |

The US Court of Appeals for the Federal Circuit denied a patent owner’s motion to voluntarily dismiss the appeal following the Federal Circuit’s decision to vacate and remand the case to the Patent Trial & Appeal Board but before the mandate issued. Cisco Sys., Inc. v. K.Mizra LLC, Case No. 22-2290 (Fed. Cir. Nov. 19, 2024) (Dyk, Reyna, Stoll, JJ.)

Computer networking companies Cisco, Forescout, and Hewlett Packard filed a petition for inter partes review (IPR) to challenge the patentability of several claims of a patent owned by K.Mizra. The Board found that the petitioners failed to show that the challenged claims were unpatentable. Cisco and Hewlett Packard appealed.

After full briefing and oral argument, the Federal Circuit issued an opinion vacating the Board’s decision and remanding with further instructions. Before the Court’s mandate issued, the parties reached a settlement and moved to voluntarily dismiss the appeal without submitting a request to vacate the Federal Circuit opinion. The motions were unopposed.

The Federal Circuit stayed the issuance of the mandate while it considered the motions and invited the US Patent & Trademark Office (PTO) to comment. The PTO requested that the Federal Circuit deny the motions because it had already entered its opinion and judgment and denied rehearing. The Court agreed, declining to depart from its principle that granting a motion to dismiss the appeal at such a late stage (days before the issuance of the mandate) would result in a modification or vacatur of its judgment that was neither required nor a proper use of the judicial system.

The Federal Circuit also emphasized that appeals from the Board require additional consideration in terms of the PTO Director’s unconditional right to intervene. The Court concluded with a reminder that the parties were free to seek dismissal from the Board on remand.



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Senate Judiciary Subcommittee Advances Two Patent Reform Bills

by | Dec 5, 2024 |

This post has been updated since its original publication date.

On November 15, 2024, the US Senate Judiciary Subcommittee on Intellectual Property advanced the Inventor Diversity for Economic Advancement (IDEA) Act, one of three significant bills it considered this year to reform the patent system. On November 21, 2024, that same subcommittee advanced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. No action has been taken by the subcommittee yet regarding the Patent Eligibility Restoration Act (PERA). It is unlikely any of these bills will become law before the new Congress begins on January 3, 2025.

The IDEA Act, sponsored by Senator Mazie Hirono (D-HI) and garnering bipartisan support, would require the US Patent & Trademark Office to seek demographic data from patent inventors residing in the United States on a voluntary basis. The bill also includes safeguards to protect the confidentiality of the collected information and ensure it is not used as part of the examination process, with a report to be submitted to Congress biannually.

By the time of the November 21 action, the subcommittee sent the PREVAIL Act, sponsored by Senators Christopher Coons (D-DE) and Thom Tillis (R-NC), to the full US Senate. In the words of Coons, the PREVAIL Act is intended to make proceedings before the Patent Trial & Appeal Board “cheaper, swifter, more efficient alternatives to federal district court.” The PREVAIL Act would enact substantial changes to post-grant and inter partes review proceedings at the Board, including by introducing a standing requirement, aligning standards more closely with district court standards, and strengthening estoppel provisions to prevent re-litigation of validity issues.

The substance of PERA and the PREVAIL Act have been reported on previously here and here, respectively. PERA would revise the standards related to patent eligibility under 35 U.S.C. § 101, which have been broadly criticized as providing insufficient predictability and certainty. PERA would overturn Supreme Court precedent by establishing specific categories of exceptions to broad patent eligibility for inventions or discoveries.

At the November 15 hearing, Coons and Tillis explained that they continue to receive feedback on PERA, which has been unsuccessfully introduced in previous years. Coons and Tillis both telegraphed optimism that PERA was moving toward being voted out of the subcommittee. After the November 21 hearing, both sponsors indicated that they hoped PERA would be voted on soon.



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UPC Court of Appeal Rules on Suspending First Instance Enforcement, Managing Director Liability

by | Nov 21, 2024 | ,

The Court of Appeal (CoA) of the Unified Patent Court (UPC) addressed a request for suspensive effect of an appeal and ruled that managing directors of an alleged patent-infringing company cannot be held liable as “intermediaries” under Article 63 of the Agreement on a Unified Patent Court (UPCA). Koninklijke Philips NV v. Belkin GmbH, UPC_CoA_579/2024, ORD_53377/2024 (UPC CoA Oct. 29, 2024) (Rombach, J.)

In contrast to German law (for example), appeals before the UPC generally do not have suspensive effect (See Article 74(1) of the UPCA). Thus, first instance decisions are immediately enforceable under Article 82 of the UPCA and Rule 354 of the UPC Rules of Procedure (RoP), which can have significant economic implications, particularly in the context of injunctions against the affected companies. To mitigate such effects, an application for suspensive effect may be filed under Rule 223.1 of the RoP.

In the present case, Philips initiated an infringement action against the Belkin Group before the Local Division Munich (CFI_390/2024), targeting not only the Belkin Group but also its subsidiaries’ managing directors. In its first instance decision, the Munich court ruled in favor of Philips and granted an injunction against Belkin and its subsidiaries’ managing directors, classifying the latter as “intermediaries” within the meaning of Article 63(1), Section 2 of the UPCA. Belkin appealed and requested suspensive effect under Rule 223.1 of the RoP.

The CoA partially granted this request, ordering suspensive effect with regard to the injunction against the managing directors. The CoA ruled that the suspensive effect of an appeal is an exception that can only be ordered in special circumstances. This involves determining whether the appellant’s interest in maintaining the status quo until the decision of the appeal exceptionally outweighs the respondent’s interest in enforcement. The CoA clarified that such circumstances exist where the decision being appealed is manifestly wrong. Whether this is the case – and whether there is, therefore, an evident violation of the law – is assessed on the basis of the factual findings and legal considerations of the first instance decision. If these findings or legal considerations prove to be untenable on summary examination, suspensive effect must be ordered.

In the present case, the CoA found a manifest error of law in the classification of the managing directors as “intermediaries” within the meaning of Article 63 of the UPCA and Article 11 of Directive 2004/48. It reasoned that managing directors, acting in their official capacity, represent the company itself and are not external to it. Therefore, the appellant company cannot be a “third party” in relation to its CEO. Accordingly, liability under Article 63(1), Section 2 of the UPCA as an intermediary cannot arise solely from the CEO functioning as a managing director.

Consequently, the CoA granted suspensive effect for the injunction against the managing directors but dismissed the application for suspensive effect in all other respects.

Practice Note: Practitioners should carefully consider the rule exception framework when applying for suspensive effect before the UPC. To be successful, a convincing, case-specific justification [...]

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Moving to Recuse? Too Little, Too Late

by | Nov 14, 2024 |

The US Court of Appeals for the Federal Circuit ruled that waiting until well after an adverse summary judgment motion to move for a district court judge’s recusal is untimely and moot, especially where an appeal from the adverse decision is already filed and where the recusal motion is based on public information. Cellspin Soft, Inc. v. Fitbit LLC, et al., Case No. 22-1526 (Fed Cir. Nov. 1, 2024) (Taranto, Prost, Reyna, JJ.) (nonprecedential).

Cellspin filed a complaint for patent infringement against Fitbit and others in October 2017. In February 2021, Fitbit amended its corporate disclosure statement to reflect the completion of its acquisition by Google (an indirect subsidiary of Alphabet). Almost a year later, in January 2022, Fitbit and the other defendants moved for summary judgment of noninfringement in their respective cases, and in June 2022, the district court granted summary judgment.

Months later, in January 2023, after the grant of summary judgment and the filing of notices of appeal from that grant, Cellspin filed a motion to recuse the district court judge based on the judge’s mutual fund investments that were likely to invest in Google. The consulting firm for which the judge’s husband worked also sold Google services, but the judge’s spouse did not do work for Google. The district court denied the motion on the merits as untimely and because the district court lacked authority to vacate the summary judgment that was already on appeal.

Applying Ninth Circuit law and reviewing for abuse of discretion, the Federal Circuit found that Cellspin’s behavior in waiting until well after it had lost on summary judgment, and almost two years after Google’s acquisition of Fitbit became final, “raises obvious concerns of lack of equity and strategic misuse of recusal.” The sources Fitbit cited for the judge’s spouse and the activities of the spouse’s employer were also public well before the summary judgment motion was granted, as were the judge’s financial disclosures.

While there is no specific time limit for seeking recusal, the Federal Circuit (citing its 1989 decision in Polaroid v. Eastman Kodak) noted that “timeliness is a well-established consideration in application of the [recusal] statute. In deciding motions to vacate orders issued by an allegedly disqualified judge, the courts have used ‘untimely’ as a synonym for ‘unfair’ when the circumstances, like those present here, are such that a grant of the motion would produce a result inequitable, unjust, and unfair.”

The Federal Circuit also noted that the risk of injustice to the parties from denying vacatur would also be essentially nonexistent here because the Federal Circuit’s concurrent holding on the summary judgment appeal against other defendants had preclusive effect, resolving Cellspin’s infringement assertions against Fitbit as well.

Practice Note: Any motion for recusal should be promptly filed when grounds for the motion become apparent.



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Equivalence Requires Element-by-Element Proof With Linking Argument

by | Nov 7, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court determination that a patent owner had not provided the “particularized testimony and linking argument” required to demonstrate equivalence under the doctrine of equivalents. NexStep, Inc. v. Comcast Cable Commc’ns, LLC, Case No. 2022-1815 (Fed. Cir. Oct. 24, 2024) (Chen, Taranto, JJ.) (Reyna, J., concurring in part and dissenting in part). In his dissent, Judge Reyna criticized the majority for ignoring the totality of the evidence presented by the patent owner and imposing a new rule requiring patentees to always present expert testimony to prove infringement under the doctrine of equivalents.

NexStep owns a patent directed to a “concierge device” for assisting users with obtaining customer support for smart devices. The claims are directed to a concierge device that initiates a technical support session in response to “a single action” (i.e., a single button press) by a user. After the claimed “single action,” the concierge device conveys consumer device identification information for the product at issue, identifies an appropriate technical support team for the product, and causes the home gateway to initiate a support session for the device and forward the consumer device information during the session.

NexStep sued Comcast for patent infringement, asserting that three tools in Comcast’s mobile smartphone application infringed the concierge device patent: Xfinity Assistant, Troubleshooting Card, and Diagnostic Check. Each of these tools assists users with troubleshooting a given device in response to the user pressing a series of buttons on a smartphone’s display. At trial, NexStep argued that pressing a series of buttons literally met the single action limitation because a single action could comprise a series of steps. By way of illustration, NexStep’s expert explained that throwing a baseball – a single action – required multiple steps: “[W]hen you throw a baseball, you pick it up, you orient it, you get it in your palm, you throw it.”

The jury returned a verdict of no literal infringement but found infringement under the doctrine of equivalents. Comcast moved for judgment as a matter of law, which the district court granted after finding that NexStep had failed to offer the “particularized testimony and linking argument” required to demonstrate equivalence. NexStep appealed.

The Federal Circuit emphasized that the doctrine of equivalents provides a “limited exception” to the principle that the claim defines the scope of the patentee’s exclusivity rights, and that a finding under the doctrine of equivalents is “exceptional.” To guard against overbroad applications of this exception, the Court’s precedent imposes specific evidentiary requirements necessary to prove infringement under the doctrine. The patent owner must provide proof on an element-by-element basis and from the perspective of someone skilled in the art, “for example through testimony of experts or others versed in the technology; by documents . . . and . . . by the disclosures of the prior art.” Finally, the patent owner must provide “particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the [...]

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Can’t Stop the FRAND: Navigating SEP Licensing Disputes

by | Nov 7, 2024 |

The US Court of Appeals for the Federal Circuit vacated a district court’s decision to deny an antisuit injunction prohibiting a patent owner from enforcing injunctions that it obtained in Columbia and Brazil on standard essential patents (SEPs). Telefonaktiebolaget LM Ericsson, et al. v. Lenovo (United States), Inc., Case No. 24-1515 (Fed. Cir. Oct. 24, 2024) (Prost, Lourie, Reyna, JJ.)

Lenovo and Ericsson entered into negotiations to cross-license their SEPs to each other. SEPs are patents declared essential to complying with a technical standard. Because SEPs by definition must be practiced to comply with a given standard, SEP holders wield significant power over standard implementers during licensing negotiations. Standard setting organizations therefore typically have an intellectual property policy under which SEP holders agree to license their SEPs on fair, reasonable, and nondiscriminatory (FRAND) terms. Here, the parties agreed that the FRAND commitment was a contract, governed by French law, that each party could enforce against the other, and that the FRAND commitment included an obligation to negotiate in good faith over licenses to SEPs.

After the parties were unsuccessful in reaching agreement, Ericsson sued Lenovo in US district court alleging that Lenovo infringed four of Ericsson’s US SEPs related to the 5G wireless communication standard. Ericsson also alleged that Lenovo breached its FRAND commitment by failing to negotiate in good faith and asked the district court to determine a FRAND rate for a global cross-license between the parties. Lenovo counterclaimed, alleging that Ericsson infringed four of Lenovo’s 5G US SEPs and asking for a similar outcome. Lenovo also asked the district court to enter an antisuit injunction prohibiting Ericsson from enforcing the preliminary injunctions Ericsson obtained in Colombia and Brazil that prohibited Lenovo from infringing Ericsson’s Columbian and Brazilian 5G SEPs. The district court denied Lenovo’s motion, following the antisuit injunction framework in the Ninth Circuit’s 2012 decision in Microsoft v. Motorola. The district court concluded that the instant suit was not dispositive of the foreign action, which was a threshold requirement to enter such an injunction. Lenovo appealed.

The Federal Circuit disagreed with the district court’s determination, finding that a party with a FRAND commitment must negotiate in good faith over a license to its SEPs before it pursues injunctive relief based on those SEPs. Interpreting the “dispositive” requirement, the Court concluded that the “requirement can be met even though a foreign antisuit injunction would resolve only a foreign injunction (and not the entire foreign proceeding), and even though the relevant resolution depends on the potential that one party’s view of the facts or law prevails in the domestic suit.” Here, the Court found that the requirement was met because the “FRAND commitment precludes Ericsson from pursuing SEP-based injunctive relief unless it has first complied with the commitment’s obligation to negotiate in good faith over a license to those SEPs.” If the district court were to determine that Ericsson had not complied with that obligation, that determination would dictate the impropriety of Ericsson pursuing SEP-based injunctive relief. Accordingly, the [...]

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