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

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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Plausible Alternative Understanding of Prior Art? So What?

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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No Need to Call for Backup at the PTAB (Sometimes)

The US Patent & Trademark Office (PTO) published a final rule entitled, Expanding Opportunities to Appear Before the Patent Trial & Appeal Board; 89 Fed. Reg. 82172 (Oct. 10, 2024).

The new rule, set to take effect on November 12, 2024, will apply to America Invents Act (AIA) proceedings, which, until now, have required that a party designate lead counsel and backup counsel. Lead counsel was required to be a registered practitioner, and non-registered practitioners could be backup counsel upon a showing of good cause.

The PTO filed a notice of proposed rulemaking on February 21, 2024, in which it proposed amending the regulations to allow the Board to permit a party to proceed without separate backup counsel as long as lead counsel is a registered practitioner. The PTO also proposed to allow a non-registered practitioner admitted pro hac vice to serve as either lead or backup counsel for a party as long as a registered practitioner was also counsel of record for that party, and to allow a non-registered practitioner who was previously recognized pro hac vice in an AIA proceeding to be considered a Board-recognized practitioner and eligible for automatic pro hac vice admission in subsequent proceedings via a simplified and expedited process.

Citing the benefits of flexibility where good cause is shown while ensuring parties are well represented, the PTO has now issued a final rule that will allow parties to proceed without backup counsel. The PTO noted that a party may demonstrate good cause, for example, by demonstrating lack of financial resources to retain both lead and backup counsel. However, the Board will question any claim of lack of financial resources where a party has also elected to pursue litigation involving the challenged patents in other forums. As a result, this rule is more likely to benefit patentees than patent challengers. The PTO also explained that the good cause analysis will center on the party, not on the counsel’s preferences. For example, the PTO is unlikely to find good cause where the lead counsel is a solo practitioner who prefers to work alone.

The PTO also issued a final rule simplifying the process for attorneys who were previously admitted to practice before the Board pro hac vice to gain admission for subsequent matters and to do so without a fee. Any attorney seeking subsequent pro hac vice admission must file a declaration or affidavit stating that all the requirements set out by the Board are met. Opposing counsel also has the opportunity to object.

Finally, the PTO rejected an amendment that would allow non-registered attorneys to serve as lead counsel.




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Unified Front: No Forfeiture by Failing to Raise Argument in Request for Rehearing

Addressing forfeiture of issues on appeal and sufficiency of the asserted prior art, the US Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board obviousness finding, explaining that a party does not waive arguments on appeal by failing to include them in a request for rehearing. Voice Tech Corp. v. Unified Patents, LLC, Case No. 22-2163 (Fed. Cir. Aug. 1, 2024) (Lourie, Chen, Cunningham, JJ.)

Unified Patents petitioned for inter partes review (IPR) of a Voice Tech patent that purported to improve upon the prior art by allowing a single mobile device to access and control various native applications and functions on a computer. Unified alleged that the challenged claims were unpatentable as obvious over three prior art references. The Board agreed and found that all of the challenged claims were unpatentable. Voice Tech appealed.

Voice Tech argued that Unified’s petition failed to identify any disclosure in the prior art that taught the “mobile device interface” claim limitation in the challenged claims because Unified’s claim analysis failed to expressly mention a “mobile device interface.” The Board dismissed this argument, finding that Unified properly mapped its analysis of other patent claims to the “mobile device interface” claim recitation and presented a sufficient argument regarding obviousness. The Federal Circuit agreed that one of the prior art references taught a “mobile device interface.” The Court found that the Board did not rely on a new theory not found in the IPR petition, but instead had mapped the “mobile device interface” limitations to the prior art because the petition itself raised the theory.

Voice Tech also argued that the Board had failed to properly interpret certain claim terms. Unified countered that Voice Tech forfeited the claim construction arguments because they were not included in Voice Tech’s request for rehearing to the Board. The Federal Circuit disagreed, finding that a party’s choice to not re-raise an argument in a request for rehearing will not, by itself, forfeit the argument for review on appeal. The Court found that since Voice Tech had raised the claim construction arguments to the Board in its patent owner’s response, it had not forfeited those arguments on appeal.

The Federal Circuit also addressed Unified’s argument that Voice Tech’s proposed claim constructions would not change the outcome of the patentability analysis given the Board’s findings that the prior art disclosed the claim terms. The Court agreed with Unified, finding that it only needed to construe claim terms as necessary to resolve the controversy. The Court found that because Voice Tech’s responsive arguments were conclusory and failed to address how Voice Tech would be prejudiced by the Board’s adopted claim construction, the Federal Circuit did not need to consider Voice Tech’s claim construction arguments.

Finally, the Federal Circuit addressed Voice Tech’s arguments that the Board erred in finding that the prior art taught certain claim limitations and that Unified’s obviousness analysis was based on hindsight bias. The Court upheld the Board’s obviousness determinations as to all challenged claims, [...]

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Private Sale Means Public Fail

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision that a private sale of a product embodying the claimed invention did not qualify as a “public disclosure” under 35 U.S.C. § 102(b)(2)(B). Sanho Corp. v. Kaijet Technology Int’l Ltd, Inc., Case No. 23-1336 (Fed. Cir. July 31, 2024) (Dyk, Clevenger, Stoll, JJ.)

Sanho owns a patent directed to a port extension apparatus designed to enhance connectivity of end-user devices (such as laptops) with other devices (such as printers). Kaijet petitioned for inter partes review (IPR) challenging certain claims of Sanho’s patent, arguing that the claims were obvious based on a prior art reference. The Board found that the patent claims were invalid because of the prior art reference’s earlier effective filing date. Sanho argued that a prior sale of its HyperDrive device by the inventor of the patent should disqualify the reference as prior art. However, the Board determined that Sanho failed to demonstrate a public disclosure of the HyperDrive sale before the prior art reference’s effective filing date. Thus, the patent was invalidated. Sanho appealed.

The Federal Circuit affirmed, explaining that the America Invents Act (AIA) redefined prior art, shifting from a first-to-invent to a first-inventor-to-file system. Under the AIA, prior art includes patents and applications filed before the patent’s effective filing date subject to exceptions for public disclosures by the inventor. Sanho argued that the HyperDrive sale fell into this exception.

The Federal Circuit dismissed Sanho’s argument that the phrase “publicly disclosed” in § 102(b)(2)(B) should encompass all types of disclosures described in § 102(a)(1), including private sales. The crux of the issue was whether placing an invention “on sale” was tantamount to a “public disclosure” under § 102(b)(2)(B). The statute states that a disclosure is not prior art if the subject matter was publicly disclosed by the inventor before the effective filing date of the prior art. Sanho argued that “publicly disclosed” includes any disclosure, even private sales. The Court disagreed, explaining that the statute’s use of “publicly” implies a narrower scope than just “disclosed.” The Court noted that the purpose of this exception is to protect inventors who make their inventions available to the public before another’s patent filing.

The Federal Circuit also relied on legislative history in support of the conclusion that “public disclosure” in § 102(b)(2)(B) means the invention must be made available to the public. Sanho argued that as long as there are no confidentiality requirements, all disclosures, even private sales, should constitute public disclosures. Again, the Court rejected that argument, noting that the statute differentiates between “publicly disclosed” and general “disclosures,” implying different meanings.

The Federal Circuit determined that § 102(b)(2)(B) protects inventors who publicly disclose their inventions from subsequent disclosures by others, ensuring that prior public disclosure by the inventor prevents a third party’s disclosure from becoming prior art. This provision aims to encourage inventors to share their innovations with the public.

Practice Note: For a disclosure to qualify as “public” under the [...]

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PTAB MTA Pilot Program to the Rescue

On review of a final written decision from the Patent Trial & Appeal Board in an inter partes review (IPR), the US Court of Appeals for the Federal Circuit found that all challenged claims were obvious but left open the possibility of the patent owner amending the claims under the Motion to Amend (MTA) Pilot Program. ZyXEL Communications Corp. v. UNM Rainforest Innovations, Case Nos. 22-2220; -2250 (Fed. Cir. July 22, 2024) (Dyk, Prost, Stark, JJ.)

ZyXEL Communications petitioned for IPR challenging claims 1 – 4, 6, 7 and 8 of a patent owned by UNM Rainforest Innovation (UNMRI). The patent relates to methods for constructing frame structures in communication systems using orthogonal frequency-division multiple access (OFDMA) technologies. The patent describes a method for constructing a frame structure with two sections, each of which is configured for a different communication system, where the second communication system is used to support high mobility users (i.e., faster moving users).

Before the Board, ZyXEL argued that claims 1 – 4, 6 and 7 were unpatentable in light of two prior art references (Talukdar and Li), and that claim 8 was unpatentable in light of Talukdar and another prior art reference (Nystrom). During the Board proceedings, UNMRI filed a contingent motion to amend if any of the challenged claims were found to be unpatentable. As part of its motion, UNMRI requested preliminary guidance from the Board pursuant to the Board’s MTA Pilot Program. In its opposition to UNMRI’s motion to amend, ZyXEL argued that UNMRI’s amended claims lacked written description support, and in its preliminary guidance, the Board agreed. UNMRI attempted to file a revised motion to amend, but the Board rejected the revised motion and instead permitted UNMRI to file a reply in support of its original motion. It also allowed ZyXEL to file a sur-reply. The Board determined that claims 1 – 4, 6 and 7 were unpatentable, but that claim 8 was not. The Board also granted UNMRI’s motion to amend and determined that the new claims were nonobvious over the prior art of record. Both sides appealed.

With respect to the Board’s decision on the obviousness of claims 1 – 4, 6 and 7, the Federal Circuit found that substantial evidence supported the ruling. UNMRI’s primary argument was that a person of skill in the art (POSA) would not have been motivated to combine Talukdar and Li, but the Court credited the Board’s reliance on ZyXEL’s expert, who demonstrated sufficient motivation to combine the two references.

The Federal Circuit reversed the Board’s finding that claim 8 had not been shown to be obvious, however. The Court noted that while the Nystrom reference may not explicitly state the benefit of the missing limitations, “a prior art reference does not need to explicitly articulate or express why its teachings are beneficial so long as its teachings are beneficial and a POSA would recognize that their application was beneficial.”

Regarding UNMRI’s motion to amend, ZyXEL argued that the Board erred in granting the [...]

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From Oops to Encore: The Board’s Premature Adverse Judgment

The Director of the US Patent & Trademark Office (PTO) overturned the Patent Trial & Appeal Board’s premature adverse judgment against a patent owner and remanded an inter partes review (IPR) proceeding based on the fact that the patent owner had initially instructed its counsel to cease work on the IPR while seeking new representation for related district court litigation, which contributed to the procedural delays. Shenzhen Xinzexing E-commerce Co., Ltd. v. Shenzhen Carku Technology Co., Ltd., IPR2024-00222 (PTO-Ofc. of Dir. July 10, 2024) (Vidal, PTO Dir.)

Shenzhen Xinzexing E-commerce Co. filed a petition for an IPR to challenge certain claims of a patent owned by Shenzhen Carku Technology Co. (Patent Owner). The petition and associated documents for the IPR were properly served on the Patent Owner at the address of record. The Board issued a notice on November 29, 2023, allowing the Patent Owner three months to file a preliminary response and requiring mandatory notice information to be submitted within 21 days. The Patent Owner did not comply with either obligation.

Following the Patent Owner’s failure to submit the required notices and response, the Board issued a sua sponte adverse judgment on May 21, 2024, interpreting the lack of response as abandonment of the IPR contest. However, on July 8, 2024, the Patent Owner filed the necessary notices and appointed new counsel, indicating that the previous counsel had been instructed to withdraw from the case and that new representation was being arranged.

The Director sua sponte overturned the Board’s adverse judgment, finding that it was premature. The Board’s communications did not clearly indicate that noncompliance with the notice requirements would result in adverse judgment. Given that the Patent Owner had shown efforts to rectify the situation by appointing new counsel and filing the required documents, the director vacated the adverse judgment and remanded the case for the Board to determine whether the petition showed a reasonable likelihood that any of the challenged patent claims were unpatentable.

Practice Note: This decision highlights the necessity of adhering to procedural deadlines and ensuring that consequences for noncompliance are clearly communicated. The Board’s failure to provide explicit notice of abandonment of the contest contributed to the premature adverse judgment, reinforcing the importance of clear procedural guidance.




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PTO Finalizes Rules Promoting Independence in PTAB Decision-Making

The US Patent & Trademark Office (PTO) announced a final rule concerning pre-issuance internal circulation and review of decisions within the Patent Trial & Appeal Board. The new rules are designed to bolster the independence of administrative patent judge (APJ) panels when issuing decisions and increase transparency regarding Board processes. 89 Fed. Reg. 49808 (June 12, 2024).

The new rules amend and codify Title 37 of the Code of Federal Regulations (37 C.F.R. §§ 43.1 – 43.6) by adding Section 43 relating to Board proceedings pending under 37 C.F.R. §§ 41 and 42. The final rule was developed in response to a July 2022 request for comments concerning interim processes and standards in place since May 2022, and an October 2023 notice of proposed rulemaking and request for comments. The final rule codifies the interim processes set forth in Standard Operating Procedure 4 (SOP4), which replaced the standards in place since May 2022.

Under the new rules codified in §§ 43.3 and 43.4, prior to issuance of a panel decision, senior PTO management and non-management APJs (as defined in § 43.2) are barred from communicating, directly or through intermediaries, with any panel member (unless they were themselves panel members) regarding panel decisions. Limited communications are permitted for procedural status and generally applicable paneling guidance that doesn’t directly or otherwise influence the paneling or repaneling of any specific proceeding. The rules do not forbid a panel member from requesting input on a decision prior to issuance from non-panel senior APJs, however. The rules further stipulate that it is within the panel’s sole discretion to adopt any edits, suggestions or feedback from non-panel APJs.

The rule is effective July 12, 2024.




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New Arguments Yield Same Unpatentability Outcome

On remand from the US Court of Appeals for the Federal Circuit in connection with inter partes review (IPR) proceedings, the Patent Trial & Appeal Board considered the petitioner’s reply arguments and evidence regarding the claim constructions that were first proposed in the patent owner’s response but again found that the claims were not unpatentable. Axonics, Inc. v. Medtronic, Inc., IPR2020-00712; -00680 (May 30, 2024) (Tartal, Jeschke, Dougal, APJ)

Axonics filed IPR petitions challenging two patents owned by Medtronic that are directed to the transcutaneous charging of implanted medical devices. In its petitions, Axonics did not propose any express claim constructions. In its preliminary response, Medtronic agreed that claim construction was not necessary. In its patent owner response, however, Medtronic – for the first time – advanced a new claim construction that differed from the interpretation of the relevant claims implied in Axonics’s claim charts. Axonics defended its own implicit construction but also offered new arguments and evidence that the prior art anticipated the patents even under the alternative construction. The Board adopted Medtronic’s new claim construction but refused to consider Axonics’s new arguments and evidence because they were first presented in the reply. The Board then found that Axonics failed to show by a preponderance of the evidence that the challenged claims were unpatentable. Axonics appealed.

Axonics did not dispute the new claim construction first introduced by Medtronic in its response and adopted by the Board; it argued only that the Board erred in refusing to consider its reply arguments and evidence under the new construction. The Federal Circuit agreed, concluding that in such a situation, “a petitioner must be given the opportunity in its reply to argue and present evidence of anticipation or obviousness under the new construction, at least where it relies on the same embodiments for each invalidity ground as were relied on in the petition.” The Court remanded for the Board to consider Axonics’s new arguments.

On remand, the Board considered Axonics’s new arguments and evidence that the challenged claims were unpatentable over the prior art under the new construction. It also considered Medtronic’s amended sur-reply. The Board again determined that none of the challenged claims were unpatentable. In its analysis, the Board pointed out that some of Axonics’s new arguments and evidence regarding what the prior art disclosed in light of the new claim construction were inconsistent with the arguments and evidence it initially offered in its petition. In particular, the Board observed that the declaration testimony of Axonics’s expert regarding the prior art, on which Axonics relied in its petition, did not support the new claim construction, even considering the expert’s supplemental declaration. The Board also rejected Axonics’s attempts in its post-remand brief to discredit Medtronic’s arguments as “untimely and wrong,” “incorrect” and “contradictory of the positions on infringement it has taken in district court.” Citing the Federal Circuit, the Board pointed out that in an IPR, the burden of persuasion to prove unpatentability by a preponderance of the evidence [...]

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Say What? Recitation Entitled to Patentable Weight When Not “Communicative Content”

Addressing when claimed printed matter is entitled to patentable weight, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s ruling involving the printed matter doctrine, explaining that the claimed subject matter was not communicative content. IOEngine, LLC v. Ingenico Inc., Case No. 21-1227 (Fed. Cir. May 3, 2024) (Lourie, Chen, Stoll, JJ.)

Financial technology company Ingenico filed three petitions for inter partes review (IPR) of certain claims from three patents owned by IOEngine, all of which shared the same title and written description. The patents, titled “Apparatus, Method and System for a Tunneling Client Access Point,” claimed a “portable device” that was “configured to communicate with a terminal.” The challenged claims recited a memory that contained program code “configured in various ways to facilitate communication … with a communications network node.”

The Board issued final written decisions, which found the challenged claims to be unpatentable for obviousness or anticipation. The Board also found several claims to be anticipated after giving no patentable weight to certain claim recitations by application of the printed matter doctrine. The Board found that the terms “encrypted communications” and “program code” claim “only communicative content” (i.e., printed matter) and that these recitations were not entitled to patentable weight.

The Board concluded that the recitation of “encrypted communications” was subject to the printed matter doctrine because “nothing in the claim … requires anything beyond sending and receiving data, even if the data is in an encrypted form.” Similarly, the Board found that the recitation “program code” was subject to the printed matter doctrine because the “recital of ‘downloading’ of program code was limited to downloading (sending or transmitting) the code, which is a communication, and no other function is recited in the claim.”

IOEngine appealed, arguing that the Board erroneously construed the term “interactive user interface,” erred in its application of the printed matter doctrine, and erred in its anticipation and obviousness analysis.

The Federal Circuit affirmed the Board’s claim construction, finding IOEngine had forfeited its proposed construction because it did not present it to the Board during the IPR proceeding. Likewise, the Court affirmed the Board’s unpatentability determination of anticipation and obviousness for those claims where the Board did not invoke the printed matter doctrine.

However, the Federal Circuit reversed the Board’s determination that the recitations “encrypted communications” and “program code” were entitled to no weight under the printed matter doctrine.

The Federal Circuit explained that courts use a two-step test to determine whether a recitation should be accorded patentable weight under the printed matter doctrine. First, a court should determine “whether the limitation in question is directed toward printed matter.” Under step one, a limitation should be considered printed matter when the limitation “claims the content of information,” meaning that “the matter [is] claimed for what it communicates.” Only if the first step is met should the court proceed to step two. In the second step, the court considers “whether the printed matter nevertheless should be given patentable [...]

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