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2019 IP Law Year in Review: Patents

Executive Summary

2019 was another important year in intellectual property law that resulted in hundreds of decisions by the courts and Patent Trial and Appeal Board (PTAB) that may affect your company’s litigation, patent prosecution or business strategy. This special report on patents discusses some of the most important cases from 2019 from the US Supreme Court, the US Court of Appeal for the Federal Circuit and the PTAB.

On January 22, 2019, the Supreme Court addressed in Helsinn Healthcare S.A. v Teva Pharmaceuticals, USA, Inc. the question of whether, under the America Invents Act (AIA), an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention. In a unanimous decision authored by Justice Clarence Thomas, the Supreme Court concluded that such a sale qualifies as prior art.

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Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase “consisting essentially of,” holding that the patentee’s actions during prosecution narrowed the claims beyond the conventional construction. Eye Therapies, LLC v. Slayback Pharma, LLC, Case No. 23-2173 (Fed. Cir. June 30, 2025) (Scarsi, Dist. J., by designation; Taranto, Stoll, JJ.)

The case involved a method for reducing eye redness using low concentrations of brimonidine, a vasoconstrictive compound. Eye Therapies owns a patent that claims methods of administering brimonidine “consisting essentially of” the active ingredient. During inter partes review (IPR), the Board applied the typical construction of that transitional phrase, allowing for the presence of other active agents as long as they did not materially affect the invention’s basic and novel properties. Based on that reading, the Board found the claims obvious over prior art references that disclosed brimonidine in combination with other drugs. On appeal, Eye Therapies argued that the Board’s construction was too broad and inconsistent with the prosecution history.

The Federal Circuit agreed. Although “consisting essentially of” is generally understood to permit unlisted ingredients that don’t materially affect the invention, the Court emphasized that this meaning can be overridden by the intrinsic record. In this case, the applicant amended the claims to avoid prior art and repeatedly argued that the invention involved only brimonidine, with no other active agents. During the original prosecution, the examiner allowed the claims on that basis. The Court found these statements to be definitional, particularly in light of the applicant’s use of “i.e.” to equate the claim language with a brimonidine-only method. Given the clarity and consistency of the applicant’s position, the Court concluded that the prosecution history required a narrower reading than the one the Board used based on the phrase’s conventional meaning.

The Federal Circuit acknowledged that the patent specification disclosed embodiments containing additional active agents. That alone, however, did not justify a broader construction. The narrowing amendment came after the specification was drafted, and the Court reiterated that not every embodiment must fall within the scope of the claims, particularly when the claims have been narrowed during prosecution. The Court also noted that other embodiments in the specification were fully consistent with the narrower interpretation. Taken together, these factors reinforced the conclusion that the applicant’s prosecution statements – not the broader illustrative disclosures – defined the proper scope of the claims.

The Federal Circuit distinguished its 2009 decision in Ecolab v. FMC, where it declined to apply prosecution history disclaimer despite similar language. In Ecolab, the patentee initially stated that peracetic acid was the “sole antimicrobial agent,” but the examiner clarified that “consisting essentially of” did not mean “solely.” The applicant never repeated the statement and secured allowance on other grounds. The specification in Ecolab also described compositions that included other known antimicrobial agents, which supported the broader interpretation. In contrast, the applicant here amended the claims, consistently [...]

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Seeing double? Director instructs Board to resolve claim construction pre-institution

The acting director of the US Patent & Trademark Office (PTO) vacated and remanded a Patent Trial & Appeal Board decision to institute two inter partes review (IPR) petitions that challenged the same claims. The acting director determined that the two petitions primarily differed with respect to claim construction. In a decision designated as “informative,” he authorized the Board to resolve claim construction pre-institution in view of the Consolidated Trial Practice Guide’s (CTPG) direction that “one petition should be sufficient to challenge the claims of a patent in most situations.” CrowdStrike, Inc. v. GoSecure, Inc., IPR2025-00068; -00070 (PTAB June 25, 2025) (Stewart, Act. Dir.) The PTO designates a decision as informative when it provides “norms on recurring issues, guidance on issues of first impression to the Board, guidance on Board rules and practices, and guidance on issues that may develop through analysis of recurring issues in many cases.”

CrowdStrike submitted two IPR petitions that challenged the same claims of GoSecure’s patent. The Board instituted both IPRs. GoSecure requested director review, asserting that instituting both petitions was an abuse of the Board’s discretion. On review, the acting director determined that the Board abused its discretion in view of the CTPG’s direction.

The acting director concluded that the two petitions did not reflect an exception to the CTPG’s direction. He determined that CrowdStrike’s petitions were primarily distinguished by the constructions applied to a claim term. The acting director explained that the Board should have construed the term at issue prior to granting institution, concluding that the Board’s institution decision amounted to improper expansion of CrowdStrike’s permitted word count and placed a substantial and unnecessary burden on the Board and GoSecure that could raise fairness, timing, and efficiency concerns. The acting director vacated and remanded the Board’s institution decision.

The acting director also instructed the Board that the patent owner should be allowed to “submit whatever arguments are necessary for the panel to make a claim construction determination” even if the patent owner has not addressed the issue.




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

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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X-Ray Vision: Court Sees Through Implicit Claim Construction

The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s final determination that challenged patent claims were not unpatentable, finding that the Board’s decision relied on an erroneous implicit claim construction. Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc., Case No. 23-2211 (Fed. Cir. May 23, 2025) (Dyk, Prost, JJ.; Goldberg, Chief Distr. J., sitting by designation).

Zeiss owns a patent related to X-ray imaging systems that incorporate projection magnification. Sigray filed a petition requesting inter partes review (IPR) of all claims in the patent. After institution, the Board issued its final written decision, which declined to hold any of the challenged claims unpatentable. Sigray appealed.

On appeal, Sigray argued that the claims were unpatentable based on a single prior art reference, Jorgensen. The Jorgensen reference “describes a system that uses an X-ray source to generate an X-ray beam, which then passes through a sample before being received by a detector.” Sigray argued that Jorgensen anticipated or rendered the challenged claims obvious. The parties agreed that Jorgensen explicitly disclosed all the limitations of the independent claim except for one reading “a magnification of the projection X ray stage . . . between 1 and 10 times.”

The parties’ arguments centered on whether the magnification limitation was inherently disclosed in Jorgensen. The Board concluded that “viewing the record as a whole, . . . [Sigray] has not shown persuasively that Jorgensen inherently discloses projection magnification within the claimed range. Sigray argued, and the Federal Circuit agreed, that the Board’s findings incorrectly relied on a flawed understanding of the claimed range. In Sigray’s view, “the Board implicitly and incorrectly construed the limitation ‘between 1 and 10’ to exclude unspecified, small divergence resulting in projection magnifications only slightly greater than 1.” This was illustrated by the Board’s determination that Sigray “failed to show that the . . . X-ray beam in Jorgensen diverges enough to result in projection magnification between 1 and 10 times.”

The Federal Circuit found that the Board’s use of the term “enough” indicated that the evidence it relied on supported a finding of some divergence in the X-ray beams. Because the beams were not completely parallel, the Court reasoned that some magnification necessarily resulted, and that even a miniscule amount (as disclosed in the prior art) fell within the claimed magnification range of 1 to 10. Since the Board made only one evidence-supported finding relevant to anticipation, the Court reversed on the independent claim and two dependent claims without remand. However, the Court remanded the case to the Board to determine whether the three remaining challenged claims, which recited further material limitations, would have been obvious.




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Prosecution Disclaimer Alive and Well, Especially in Closed Claim

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc. v. Alkem Lab’ys Ltd., Case No. 23-1977 (Fed. Cir. Apr. 8, 2025) (Moore, Chen, Murphy, JJ.)

Azurity owns a patent directed to a nonsterile, stable liquid formulation of vancomycin hydrochloride, specifically designed for oral administration to treat Clostridium difficile infections. Following Alkem’s submission of an Abbreviated New Drug Application (ANDA), Azurity brought a Hatch-Waxman Act claim against Alkem for infringement of certain claims of the patent. The district court found that Azurity had disclaimed the presence of propylene glycol in the claimed formulation during the prosecution. Since Alkem’s ANDA product contained propylene glycol, the district court held that it did not infringe. Azurity appealed.

The Federal Circuit affirmed, focusing on the patent’s prosecution history and noting that Azurity used the lack of propylene glycol to distinguish its claimed invention from the prior art. The Court noted that this distinction was made during prosecution multiple times in response to the examiner’s rejections, and that Azurity had added negative claim limitations that specifically omitted propylene glycol from the scope of the claims.

The Federal Circuit also noted that Azurity used a “consisting of” transitional phrase to narrow the claims and relied on the closed transition to overcome the prior art. The Court explained that “consisting of” is a closed transition that limits the claim scope to only the recited components. By using this transition and not including propylene glycol as one of the claim components, Azurity effectively disclaimed propylene glycol from the invention. Therefore, the Court found that omission of propylene glycol during patent prosecution was “clean, unambiguous, and complete.”

Azurity argued that a pretrial stipulation between the parties, which stated that “[s]uitable flavoring agents for use in the asserted claims include flavoring agents with or without propylene glycol,” should preclude the application of the disclaimer. The Federal Circuit did not find this argument persuasive, concluding that the stipulation did not alter the clear and unambiguous disclaimer made during prosecution, nor did it affect the noninfringement finding. Since Alkem’s ANDA product contained propylene glycol and Azurity disclaimed inclusion of propylene glycol, there was no infringement.




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When “It’s Obvious” Just Isn’t Enough: Challenger’s Burden to Prove Obviousness

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision that a patent was not obvious because the petitioner failed to show sufficient support of obviousness based on prior art. AMP Plus, Inc. v. DMF, Inc., Case No. 23-1997 (Fed. Cir. Mar. 19, 2025) (Lourie, Bryson, Reyna, JJ.)

DMF owns a patent directed to a compact recessed lighting system designed for installation in a standard electrical junction box. In 2019, AMP, doing business as ELCO, petitioned for inter partes review of several claims of the patent on three grounds of unpatentability:

  • Anticipation by a prior reference
  • Obviousness based on a combination of two references
  • Further obviousness based on an additional source.

The Board found that one claim was anticipated but ruled that ELCO failed to prove unpatentability of the other claims, including the claim at issue on appeal. The claim at issue describes a system with wires connected to a driver and a first connector, coupled to a second connector that in turn is connected to the building’s electrical system. This specific connection was referred to as “Limitation M.” ELCO appealed. In that earlier appeal (2022), the Federal Circuit affirmed the Board’s ruling on all claims except the claim at issue and remanded the case back to the Board for further analysis.

On remand, the Board concluded that ELCO failed to demonstrate the unpatentability of the claim at issue because ELCO’s petition lacked a substantive analysis of Limitation M. The Board found ELCO’s argument that a prior art marine lighting system could be adapted for the claimed building use unsupported by evidence and ruled that the claim at issue was not obvious. Again, ELCO appealed.

ELCO raised two main arguments. First, it argued that the Board erred in not determining that the claim at issue was anticipated by a prior reference, as the Board had previously found another claim to be anticipated by the same reference. The Federal Circuit rejected this argument because ELCO had only challenged the claim at issue on the basis of obviousness in its original petition, not anticipation. Since the issue of anticipation was not raised in the petition, the Court determined that ELCO could not introduce this new ground of unpatentability on appeal.

Second, ELCO argued that its petition had sufficiently demonstrated the obviousness of Limitation M based on the prior references. The Federal Circuit disagreed, finding that ELCO’s petition did not adequately address the specific requirement for coupling the system to a building’s electrical infrastructure. The petition failed to discuss how the recessed lighting system would be installed in a building, and the references cited did not provide adequate support for the argument of obviousness for this particular limitation.

The Federal Circuit emphasized that it was not the Board’s responsibility to supplement the petitioner’s arguments or search for evidence to support an inadequately supported claim challenge. The Court reiterated that an obviousness analysis does not require the Board to fill gaps in the petitioner’s original [...]

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CJEU Recognizes Cross-Border Jurisdiction of National Courts, Long-Arm Jurisdiction of UPC

The Court of Justice of the European Union (CJEU) issued a decision significantly expanding the capabilities of both the Unified Patent Court (UPC) and the national courts in EU Member States to issue cross-border injunctions and adjudicate on patent infringement acts in countries (seemingly) outside their respective jurisdiction. Case C-339/22 (CJEU, Grand Chamber Feb. 25, 2025) ECLI:EU:C:2025:108.

Background

German company BSH Hausgeräte GmbH owns a European patent that is validated in several EU Member States and non-EU countries such as Turkey. BSH sued Swedish company Electrolux AB before a Swedish court for infringement of all national parts of the European patent (including the Turkish part).

Electrolux argued that the parts of the patent validated outside Sweden were invalid and that the Swedish court accordingly lacked jurisdiction to rule on these infringement claims. Electrolux relied on Article 24(4) of Regulation (EU) 1215/2012, the Brussels I bis Regulation, which confers exclusive jurisdiction for questions of patent validity on the courts of the state where a patent is registered.

The Swedish court of first instance declared that it did not have jurisdiction to rule on infringement of any non-Swedish parts of the patent. BSH appealed, and the Swedish Court of Appeal referred key questions to the CJEU about the interplay between Articles 4(1) and 24(4) of the Brussels I bis Regulation. Article 4(1) of the Regulation grants the courts of EU Member States general jurisdiction over all infringement actions committed by a person or company domiciled in their territory (regardless of where the infringement occurred). One of the relevant questions in this case was whether, in light of Article 24(4) of the Regulation, the court hearing the patent infringement action loses jurisdiction when an invalidity defense is raised.

Long-Arm Jurisdiction and Invalidity Defense

The CJEU clarified that Article 24(4) of the Regulation must be interpreted narrowly. According to the CJEU, the “validity of patents” mentioned in Article 24(4) of the Regulation only pertains to validity challenges that would lead to the annulment of the patent with effect erga omnes. Such erga omnes validity proceedings must still be brought before the courts of the forum of registration (e.g., the German Federal Patent Court in the case of the German part of a European patent). However, the CJEU considers that Article 24(4) of the Regulation does not apply to an inter partes invalidity defense raised in patent infringement litigation. Consequently, according to Article 4(1) of the Regulation, a court of an EU Member State in which the infringement case is being heard can decide on patent infringements in another EU Member State or in a third (non-EU) country and does not lose its jurisdiction if an invalidity defense is raised. Patent proprietors can therefore obtain cross-border injunctions in national courts of EU Member States (as well as before the UPC, even in states that do not take part in the UPC), and the courts remain jurisdictionally competent even if the infringer imposes an invalidity defense.

Where a third country outside of [...]

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Bottling the Truth: Equivalence and Reverse Equivalence

The US Court of Appeals for the Federal Circuit ruled that the “substantially the same way” comparison in connection with a doctrine of equivalents (DOE) analysis involving a means-plus-function claim limitation should focus on the overall structure corresponding to the claimed function, not on unclaimed structure. Steuben Foods, Inc. v. Shibuya Hoppmann Corp., Case No. 23-1790 (Fed. Cir. Jan. 24, 2025) (Moore, Hughes, Cunningham, JJ.)

Steuben Foods holds patents for an aseptic bottling system designed to sterilize and fill bottles with foodstuffs at speeds exceeding 100 bottles per minute, making the technology suitable for high-volume food production. Steuben sued Shibuya for infringing its patents. At trial, Steuben successfully demonstrated that Shibuya’s aseptic bottling system infringed a patent claim related to a “second sterile region,” a feature designed to pre-sterilize a valve mechanism and prevent contamination. The jury awarded Steuben more than $38 million in damages and, in doing so, rejected Shibuya’s defense under the reverse doctrine of equivalents (RDOE). The RDOE is a rarely invoked defense that is asserted when an accused product, although meeting the literal terms of a claim, operates on fundamentally different principles and thus does not infringe. Despite the jury’s verdict, the district court granted judgment as a matter of law (JMOL) of noninfringement, holding that Shibuya’s RDOE defense precluded infringement. Steuben appealed.

The Federal Circuit reversed the JMOL based on the RDOE, finding that the district court improperly weighed evidence that should have been left to the jury. The Court emphasized that Steuben’s expert testimony constituted substantial evidence supporting the jury’s findings and warranted deference. The Court also rejected Shibuya’s narrow construction of the claimed “second sterile region,” which would have excluded food flow, and affirmed the broader interpretation adopted by the district court (an interpretation the Court noted better aligned with the claim language).

The Federal Circuit noted that it had “previously described RDOE as an ‘anachronistic exception, long mentioned but rarely applied.’” While the Court declined to definitively rule on the RDOE’s continued viability under the Patent Act of 1952, it favorably noted Steuben’s argument that “if a device literally falls within the scope of a claim, but the accused infringer believes the claim is too broad and its device should not infringe, the appropriate recourse is a § 112 challenge, not a claim of noninfringement under RDOE.” In this case, the Federal Circuit concluded that even if Shibuya had made a prima facie case under RDOE that the principle of operation of the accused product was so far removed from the asserted claim, “the jury’s verdict should not have been overturned under RDOE because [Steuben’s expert] provided rebuttal testimony that the jury was entitled to credit. JMOL of noninfringement was therefore improper.”

The district court had also analyzed whether, under the DOE, claimed structures, such as conveyor plates and systems, were equivalent to Shibuya’s rotary wheels and neck grippers. The district court concluded they were not. The district court had construed the term “means for filling the aseptically disinfected plurality of bottles [...]

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No Co-Inventorship Absent Corroborated Conception

In a patent case concerning cryptocurrency data mining, the US Court of Appeals for the Federal Circuit affirmed a district court’s grant of summary judgment and its ruling that a state law conversion claim was preempted by patent law of inventorship. The Court also affirmed the denial of a correction to the inventorship claim. BearBox LLC v. Lancium LLC, Case No. 23-1922 (Fed. Cir. Jan. 13, 2025) (Stoll, Chen, Bryson, JJ.)

BearBox was an entity founded by Austin Storms that developed and designed mobile cryptocurrency data centers. It operated a half-megawatt data center but was unprofitable as a consequence of the high cost of electricity and the data center’s high energy requirements. Lancium was an entity that aimed to co-locate data centers at wind farms to use the highly variable power generated for data mining but sell excess electricity to the grid when electricity cost was high. BearBox and Lancium met in 2019 at a cryptocurrency mining summit. At that time, BearBox was looking to find customers for its newly developed BearBox containers, and Lancium was in the market for those containers. Both BearBox and Lancium had developed similar software to detect profitable time periods for cryptocurrency mining. Their systems aimed to mine cryptocurrency during periods when electricity prices were low, while selling the energy to the grid when prices were high. Lancium disclosed these concepts in an international patent application filed 15 months before Storms met anyone at Lancium.

BearBox’s system was discussed over dinner at the summit and in a single email exchange afterwards. However, BearBox never disclosed any source code associated with the BearBox system to Lancium. The email exchange was the last communication between the two parties. About five months after the meeting, Lancium filed a patent application that related to a set of computing systems configured to perform computational operations using electricity from a power grid and to a control system that monitored a set of conditions and received power option data based at least in part on a power option algorithm. After that application matured into a patent, BearBox filed suit asserting sole or joint inventorship of the patent and conversion under Louisiana state law.

Lancium moved for summary judgment on the conversion claim. The district court granted the motion, noting that federal patent law preempted the claim. However, the district court denied Lancium’s motion for summary judgment on the inventorship claims – claims that were then heard at a bench trial. At trial, the district court concluded that BearBox failed to prove by clear and convincing evidence that BearBox’s founder, Storms, conceived any part of the claimed invention. BearBox appealed.

The Federal Circuit began by assessing the ruling on preemption of BearBox’s conversion claim. Relying on its 2005 decision in Ultra-Precision Mfg. v. Ford Motor, the Court noted that although the state law of conversion does not squarely implicate federal patent law, the way a conversion claim is pled may “[stand] as an obstacle to the accomplishment and execution of the full purposes [...]

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