IP UPDATE

CRISPR Clarity: Enablement Is Analyzed Differently Under §§ 102 and 112

by Peter Marston | Jun 18, 2025 | Life Sciences, Patents

In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was enabling for purposes of anticipation, even in the absence of working examples. Agilent Technologies, Inc. v. Synthego Corp., Case Nos. 23-2186; -2187 (Fed. Cir. June 11, 2025) (Prost, Linn, Reyna, JJ.)

The case centers on CRISPR, the gene-editing technology that has reshaped the frontiers of biology and biotechnology. Agilent owns patents that claim chemically modified guide RNAs (gRNAs) designed to improve stability and performance in CRISPR-Cas systems. Synthego filed an inter partes review (IPR) petition asserting that the patents were unpatentable. The Board found all claims unpatentable, relying on a 2014 publication by Pioneer Hi-Bred that disclosed similar modified gRNAs. Agilent appealed.

Agilent challenged the Board’s finding that the prior art was enabling, arguing that Pioneer Hi-Bred merely proposed a research plan without demonstrating which specific modifications would yield functional gRNAs. Agilent emphasized that the reference lacked working examples and disclosed numerous nonfunctional sequences, contending that a skilled artisan would not have been able to identify a successful embodiment without undue experimentation. It also argued that the nascent state of CRISPR technology in 2014 compounded the unpredictability, making the reference non-enabling. In support, Agilent relied heavily on the Supreme Court’s 2023 decision in Amgen v. Sanofi, where the Supreme Court invalidated a broad genus claim for failing to enable its full scope.

The Federal Circuit was not persuaded. The Court drew a clear distinction between enablement under § 112 (which governs patent validity) and enablement under § 102 (which governs anticipation). The Court explained that the bar is lower for the latter, and that a prior art reference need only enable a single embodiment within the scope of the claim. While Amgen involved § 112, the Court emphasized that this case turned on § 102, where the standard is less demanding.

The Federal Circuit grounded this distinction in both the statutory text and the underlying purpose of the respective provisions. Statutorily, § 112 requires that a patent specification enable a person of ordinary skill in the art to “make and use” the invention. Section 102, by contrast, contains no such requirement. This divergence reflects a difference in purpose: § 112 ensures that the patentee does not claim more than they have taught, thereby preventing overbroad monopolies. As the Supreme Court explained in Amgen, “[t]he more a party claims, the broader the monopoly it demands, the more it must enable.” But the Federal Circuit emphasized that the Supreme Court’s reasoning in Amgen was rooted in the patentee’s burden to support the full scope of a genus claim under § 112. That concern, the Court explained, does not apply in the § 102 context, where the question is not how much the prior art claims, but whether it teaches enough for a skilled artisan to practice at least one embodiment without undue [...]

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Radio Silence Alone Doesn’t Prove Equitable Estoppel Defense

by Dexter Hamilton | Jun 18, 2025 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment grant based on an equitable estoppel defense, finding that the accused infringer failed to show that the patent owner’s silence or inaction influenced the decision to migrate to the accused system. Fraunhofer-Gesellschaft v. Sirius XM Radio Inc., Case No. 23-2267 (Fed. Cir. June 9, 2025) (Lourie, Dyk, Reyna, JJ.)

In 1998, Fraunhofer licensed patents related to satellite radio to WorldSpace International Network. This license was exclusive, with the right to sublicense. However, Fraunhofer also began a collaboration with XM Satellite Radio to develop satellite radio and required that XM obtain a sublicense from WorldSpace. XM ultimately launched a “high-band” satellite radio system. In 2008, XM joined Sirius Satellite Radio, to form Sirius XM (SXM). Sirius Satellite Radio had its own “low-band” system. The low- and high-band systems were incompatible, so SXM investigated which system it would use eventually, and it ultimately decided to shift toward the high-band system.

Meanwhile, WorldSpace filed for bankruptcy in 2008. In 2010, Fraunhofer, in its view, terminated its licensing agreement with WorldSpace. In 2011, XM formally merged with SXM. It is disputed whether SXM was licensed to the asserted patents after these events, but regardless, Fraunhofer remained silent until 2015, when it notified SXM that it believed that because its agreement with WorldSpace was supposedly terminated in 2010, the rights in the asserted patents had reverted to Fraunhofer, and thus SXM was not licensed and was infringing. Fraunhofer filed suit. However, the district court found that because of Fraunhofer’s silence, Fraunhofer was equitably estopped from bringing the patent infringement claims against SXM. Fraunhofer appealed.

The Federal Circuit reversed. There are three requirements for a successful equitable estoppel defense:

The patentee must engage in misleading conduct leading the accused infringer to reasonably infer that the patentee does not intend to assert its patent against the accused infringer.
The accused infringer must rely on that conduct.
As a result of that reliance, the accused infringer must be in a position such that it would be materially prejudiced if the patentee was allowed to proceed with its infringement action.

The Federal Circuit agreed with the district court that Fraunhofer’s refusal to raise the issue of potential infringement from 2010 until 2015, despite asserting that it reacquired the rights to the asserted patents in 2010, was misleading conduct. Fraunhofer knew that SXM’s product may have infringed the asserted patents and had previously required SXM to obtain a license to those patents. Fraunhofer also had built allegedly infringing features. Thus, it was reasonable for SXM to infer that Fraunhofer would not bring a claim against SXM.

However, the Federal Circuit disagreed with the district court on the issue of reliance. To show reliance, the Court explained that SXM must have established “that it at least considered Fraunhofer’s silence or inaction and that such consideration influenced its decision to migrate to the accused high-band system.” The evidence did not indisputably establish influence over SXM’s [...]

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Jurisdiction Affirmed: Trademark Ripples Reach US Shores

by Sydney E. McDermott | Jun 18, 2025 | Trademarks

Addressing for the first time the issue of whether a foreign intellectual property holding company is subject to personal jurisdiction in the United States, the US Court of Appeals for the Eleventh Circuit reversed a district court’s dismissal and determined that the holding company, which had sought and obtained more than 60 US trademark registrations, had sufficient contacts with the US to support exercise of personal jurisdiction. Jekyll Island-State Park Auth. v. Polygroup Macau Ltd., Case No. 23-114 (11th Cir. June. 10, 2025) (Rosenbaum, Lagoa, Wilson, JJ.)

Polygroup Macau is an intellectual property holding company registered and headquartered in the British Virgin Islands. Jekyll Island is a Georgia entity that operates the Summer Waves Water Park and owns a federally registered trademark for the words SUMMER WAVES. In 2021, Jekyll Island discovered that Polygroup Macau had registered nearly identical SUMMER WAVES marks. After Polygroup Macau asked to buy Jekyll Island’s domain name, summerwaves.com, Jekyll Island sued Polygroup Macau for trademark infringement and to cancel Polygroup Macau’s marks. The district court dismissed the case for lack of personal jurisdiction, finding that “the ‘causal connection’ between Polygroup Macau’s activities in the United States and Jekyll Island’s trademark claims was too ‘attenuated’ to support personal jurisdiction.” Jekyll Island appealed.

The Eleventh Circuit reviewed whether personal jurisdiction was proper under Federal Rule of Civil Procedure 4(k)(2), also known as the national long-arm statute. Rule 4(k)(2) allows courts to exercise personal jurisdiction over foreign defendants that have enough contacts with the US as a whole, but not with a single state, to support personal jurisdiction. To establish personal jurisdiction under Rule 4(k)(2), a plaintiff must show that:

Its claim arises under federal law.
The defendant is not subject to jurisdiction in any state’s courts of general jurisdiction.
“[E]xercising jurisdiction is consistent with the United States Constitution and laws.”

The parties agreed that the first two elements were satisfied; the only dispute was whether the exercise of jurisdiction was consistent with due process.

The Eleventh Circuit noted that in the patent context, the Federal Circuit determined that a foreign defendant that “sought and obtained a property interest from a U.S. agency has purposefully availed itself of the laws of the United States.” The Eleventh Circuit found that a trademark registration is even stronger than patent rights because a “trademark registrant must show that he is already using the mark in U.S. commerce to identify and distinguish goods or intends to soon.” Polygroup Macau had more than 60 registrations and allowed other companies and customers to use those marks, which was enough to establish that it had sought out the benefits afforded under US law.

Additionally, while Polygroup Macau did not license its trademark rights, it permitted other related companies to use the SUMMER WAVES trademark to identify their products. Products marked with Polygroup Macau’s registered mark were sold in the US through dozens of retailers. Although there were no formal written agreements, the Eleventh Circuit found that Polygroup Macau exercised some degree of control [...]

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No Blank Check: Vendor Can’t Claim Declaratory Judgment From Customer Lawsuits Alone

by Cecilia Choy, Ph.D. | Jun 18, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a declaratory judgment action, explaining that declaratory judgment jurisdiction does not “arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee.” Mitek Sys., Inc. v. United Servs. Auto. Ass’n, Case No. 23-1687 (Fed. Cir. June 12, 2025) (Taranto, Schall, Chen, JJ.)

Mitek develops a mobile image capture software development kit called MiSnap. United Services Automobile Association (USAA) sent letters to and filed infringement claims against several of Mitek’s bank customers. Mitek sought a declaratory judgment that it and its customers did not infringe four USAA patents related to mobile check deposits, arguing that it had standing based on a reasonable apprehension of suit and indemnity demands from its customers. The district court dismissed the declaratory judgment action, which Mitek appealed. The Federal Circuit vacated and remanded the district court’s dismissal, finding that the decision lacked adequate explanation and support.

On remand, the district court again analyzed Mitek’s two jurisdictional bases for its declaratory judgment action: potential liability for infringement and alleged demands for indemnity made by licensees after USAA sent letters seeking to license USAA patents. The district court again dismissed the case, determining that Mitek could not establish a case or controversy between USAA and Mitek as to infringement, and determining that indemnification agreements and USAA’s letters to Mitek customers did not create a reasonable potential for Mitek’s indemnification liability. Even if it had jurisdiction, the district court stated that it would exercise its discretion to decline jurisdiction, because the best means by which Mitek could defend the MiSnap software used by the banks was to intervene in a future litigation brought by USAA against a Mitek customer regarding the asserted patents. Mitek again appealed.

The threshold question for declaratory judgment jurisdiction is “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

Regarding Mitek’s infringement basis, the Federal Circuit found that Mitek did not establish a reasonable potential of the suit for infringement. The Court’s consideration also included post-filing events, including settlements of related customer suits and Patent & Trial Appeal Board decisions invalidating asserted patent claims. These developments further undermined any ongoing controversy. The Court then addressed the allegations of direct infringement, induced infringement, and contributory infringement:

Direct Infringement. Mitek admitted that MiSnap alone did not perform all elements of any asserted claim. USAA also never accused MiSnap of satisfying every limitation of an asserted claim. Instead, MiSnap’s “unadulterated” software implemented by third-party banks failed to meet certain elements of the asserted claims. And although Mitek stated that it evaluated the complete mobile deposit system, Mitek could not have had a reasonable apprehension of suit based on testing its [...]

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In Determining Subject Matter Eligibility, the Name of the Game Is the Claim

by Tim Dunker | Jun 18, 2025 | Patents

The US Court of Appeals for the Federal Circuit overturned a district court grant of summary judgment of patent eligibility under 35 U.S.C. § 101 in connection with a patent directed to remote check deposit technology, explaining that details in the specification but not recited in the claims could not be relied on to meet the test for abstraction. United Services Automobile Association v. PNC Bank N.A., Case No. 23-1639 (Fed. Cir. May 6, 2025) (Dyk, Clevenger, Hughes, JJ.)

The patent in issue was directed to a system for allowing a customer to deposit a check using the customer’s handheld mobile device and claimed a “system configured to authenticate the customer using data representing a customer fingerprint.”

After the United Services Automobile Association (USAA) sued PNC for infringement of the patent, both parties filed motions for summary judgment seeking an adjudication as to whether the claims were patent eligible under § 101. The district court granted USAA’s motion, finding that the claims were not directed to an abstract idea and therefore were patent eligible. After a five-day trial, the jury found no invalidity of the asserted claims and found that PNC had infringed. PNC appealed.

The Federal Circuit found that the asserted claim was directed to the abstract idea of depositing a check using a handheld mobile device. At Alice step one, the Court found that the invention claimed steps for carrying out the process of a mobile check deposit by “instructing the customer to take a photo of [a] check,” “using [a] wireless network” to transmit a copy of the photo, and having the configured system “check for errors.” The Court determined that this amounted to a routine process implemented by a general-purpose device. The Court further found that the claim recited routine data collection and analysis steps that have been traditionally performed by banks and people depositing checks – namely reviewing checks, recognizing relevant data, checking for errors, and storing the resultant data.

USAA argued that “accomplishing check deposit on a consumer device required the development of extremely non-obvious algorithms.” The Federal Circuit rejected this argument, noting that the Court focuses on the claims, not the specification, to determine eligibility, because “the level of detail in the specification does not transform a claim reciting only an abstract concept into a patent-eligible system or method.” Since the claims did not recite the algorithms and neither the specification nor the claims contained a “clear description of how the claimed system is configured,” but only “a concept of improving the check deposit process,” the Court found that the claimed subject matter was directed only to an abstract idea.

At Alice step two (not addressed by the district court, which concluded that the claims passed muster at Alice step one), the Federal Circuit considered whether the claim elements contained an inventive concept sufficient to transform the abstract idea into a patent-eligible application. The Court found no inventive concept present, as computer-mediated implementation of routine or conventional activity is not enough to provide [...]

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