Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Rembrandt’s 019 patent is directed to test assay devices and methods for testing biological fluids. The test assay device receives a fluid sample “introduced directly to the sample loading zone” of one or more assay test strips. Alere petitioned for inter partes review.The Patent Trial and Appeal Board found that claims 3–6 and 10 would have been unpatentable for obviousness. Rembrandt argues that the Board erred by relying on Alere’s new theories asserted for the first time in its reply brief. The Federal Circuit affirmed. Alere did not offer new theories. Alere’s reply argument was responsive to Rembrandt’s arguments and the Board’s observations. Substantial evidence supports the Board’s determinations. The Board was presented with “two alternative theories” about what the prior art discloses; the court reasoned that it was not its task “to determine which theory we find more compelling.” View "Rembrandt Diagnostics, LP v. Alere, Inc." on Justia Law

Medtronics’s patents, which share a specification, relate to the transcutaneous (through the skin) charging of implanted medical devices. This charging occurs by inductive coupling, whereby energy is transferred between a primary coil in the external charger and a secondary coil in the implanted device when the two coils are placed in proximity to each other. The patents seek to improve charging efficiency by automatically varying the power output of the external charger based on various measured parameters of the current passing through the implanted device.In two inter partes review (IPR) determinations. The Patent Trial and Appeal Board held that the petitioner had failed to show that claims of the patents were unpatentable as anticipated or obvious. In each decision, the Board adopted a "two-input" claim construction first presented in the patent owner’s response after the institution decision and declined to consider the petitioner’s reply arguments and evidence under the new claim construction, reasoning that the petitioner had not identified anywhere in the petition that the two-input anticipation arguments had been made.The Federal Circuit vacated. The Board’s refusal to consider the new arguments and evidence was erroneous. The court remanded for the Board to consider the merits of Axonics’ responsive arguments and evidence under the new claim construction. View "Axonics, Inc. v. Medtronic, Inc." on Justia Law

Bufkin served in the Air Force from 2005-2006. In 2013, he sought service connection for an acquired psychiatric disorder. VA medical records reflected his visits with a VA psychiatrist, who wrote that he met the criteria for PTSD but did not identify the specific stressor or whether the stressor related to Bufkin’s military service. The VA scheduled an examination with a VA psychiatrist, who opined that his “symptoms do not meet the diagnostic criteria for PTSD.” Bufkin filed a notice of disagreement, arguing that the favorable opinion and the unfavorable opinion were in equipoise, and therefore, VA was legally obligated to grant service connection. Bufkin underwent another VA examination with another examiner, who concluded that his symptoms did not meet the diagnostic criteria for PTSD. The VA continued its denial of service connection. While his appeal was pending, another VA psychiatrist opined that in addition to a severe anxiety disorder, Bufkin “suffers from chronic PTSD.”The Board of Appeals denied service connection, finding that the preponderance of evidence supported a finding that Bufkin does not have PTSD. The Veterans Court and Federal Circuit affirmed. There was no error in the Board’s application of the benefit of the doubt rule, 38 U.S.C. 5107(b): “[w]hen there is an approximate balance of positive and negative evidence” the Secretary “shall give the benefit of the doubt to the claimant.” The Board considered conflicting medical statements but found that the rule did not apply. View "Bufkin v. McDonough" on Justia Law

Katana, a California-based distributor of high-end wheels and tires, was the importer of record for 386 entries of passenger vehicle and light truck tires from China in 2009-2012 and supplied Customs and Border Protection with invoices that listed prices lower than what Katana actually paid its Chinese vendors. Due to this error, Katana undercalculated the amount of safeguard duties, regular customs duties, harbor maintenance fees, and merchandise processing fees it owed by $5,742,483.80. Customs issued a demand to Katana for the unpaid duties and fees and later filed suit under 19 U.S.C. 1592(d).Katana sought dismissal for lack of jurisdiction because the government had filed suit after the statute of limitations, 19 U.S.C. 1621, had run. Katana stated that, although it had signed a waiver of the limitations period on October 25, 2016, it had revoked the waiver before the expiration of the limitations period. The Trade Court found that Katana had properly revoked its waiver and that the suit was untimely.The Federal Circuit reversed. The statute of limitations in 19 U.S.C. 1621 is not a jurisdictional time limit; it is subject to waiver and equitable tolling. On remand, Katana can assert an affirmative defense concerning the invalidity of its waiver. View "United States v. Katana Racing, Inc." on Justia Law

Cavaciuti served in the Army, 1965-1967. In 2020, the Board of Veterans’ Appeals granted him entitlement to a total disability rating due to individual unemployability (TDIU) and directed the VA to assign him an effective date. The VA nonetheless denied Cavaciuti’s claim, finding that he was capable of gainful employment. Cavaciuti sought a writ of mandamus. After negotiations, the VA informed the Veterans Court that it had granted Cavaciuti entitlement to TDIU with a 2008 effective date. Cavaciuti argued that the case was not moot because the RO had not invalidated its erroneous rating decision and that the VA misused confidential settlement information to render the case moot.The court dismissed Cavaciuti’s petition as moot because the VA had provided him with the relief that he sought. Cavaciuti sought attorney fees and expenses under the Equal Access to Justice Act. The Veterans Court denied the application, finding that Cavaciuti did not satisfy the criterion for prevailing party status because the dismissal order did not award benefits, change the parties’ legal relationship, or otherwise address the merits of Cavaciuti’s writ petition. The Federal Circuit affirmed. There was no judicial change in the parties' legal relationship. The VA implemented the Board’s decision, as Cavaciuti requested, following a settlement rather than based on any court order. The fact that the government’s representations would prevent future changes does not render the dismissal a judicial imprimatur sufficient to make Cavaciuti the prevailing party. View "Cavaciuti v. McDonough" on Justia Law

Johnson first enlisted in 1999; in 2006 he extended his enlistment for 23 months to affiliate with the Marine Corps. Active Reserve (AR) Program. He subsequently reenlisted for terms of three and four years; his scheduled end of active service was November 2015. In March 2013, the Corps issued permanent change of station (PCS) orders for Johnson to relocate from Virginia Beach to Phoenix. Johnson unsuccessfully tried to have his orders changed, citing personal hardship. Johnson stayed in Virginia despite being counseled. He signed a “page 11,” acknowledging that he was assigned code RE-3O for failing to comply with PCS orders, and was not eligible for promotion, reenlistment, commissioning or warrant officer programs, special education programs, or involuntary separation pay unless specially authorized. Johnson was transferred into the Individual Ready Reserve (IRR) program and received a DD Form 214 reflecting the RE-3O code. Months later, the Reserve mobilized Johnson back to the AR Program, stationed in Quantico, and preliminarily approved him for appointment to warrant officer. His appointment was delayed due to the RE-3O code.Johnson reenlisted for two years and unsuccessfully petitioned the Board of Naval Corrections to remove the RE-3O code and grant his appointment. The Federal Circuit held that Johnson was properly released from the AR Program and transferred to the IRR under the procedures described in the AR Program Policy Manual. Johnson was not entitled to additional notice and a separation board before his transfer. View "Johnson v. United States" on Justia Law

Royal imported five entries of pencils to the United States in 2017-2018 and was accused of evasion of antidumping duties under the Enforce and Protect Act of 2015, 130 Stat. 155, and related regulations, 19 C.F.R. 165. A competitor alleged that Royal was transshipping pencils from China through the Philippines, falsely claiming the pencils to be of Philippine origin and not subject to the antidumping duties assessed on certain pencils from ChinaCustoms conducted a site visit to the Philippines manufacturer. The resulting Verification Report concluded that the manufacturer did not have the capability to produce sufficient quantities of pencils to account for the number of pencils imported to the U.S. in 2018. Customs provided Royal with only a redacted version of the report, including neither the numbers used to calculate production capacity nor the final production capacity determinations. The redacted version also omitted other confidential business information, such as photographs and information about certain invoices and purchase orders. Royal sought to file a rebuttal. Customs determined that the report did not contain new factual information and denied the request.The Federal Circuit first held that it had jurisdiction, although the entries had been liquidated, then remanded. The failure to provide access to the redacted information violated due process. Under the Customs regulation, Royal must be given an opportunity to rebut the information with its own evidence. View "Royal Brush Manufacturing Inc. v. United States" on Justia Law

Perciavalle, serving in the Army from 1962-1964, injured his knee, which required surgery. The VA awarded Perciavalle a 10 percent disability for medial menisectomy under Diagnostic Code (DC) 5259 for “[c]artilage, semilunar, removal of, symptomatic.” In 1971, Perciavalle underwent another orthopedic examination. The VA did not increase Perciavalle’s disability rating. Perciavalle did not appeal. In 2015, Perciavalle requested a reopening of the 1971 rating decision for clear and unmistakable error (CUE), claiming that he was entitled to two separate disability ratings, one for slight instability of the knee under DC 52571 and another based on the 1971 examination for limitation of motion of flexion and discomfort secondary to arthritis under DC 5003-5260. Perciavalle argued that the 1971 x-ray “clearly show[ed] degenerative changes” as compared to the 1966 examination. The regulations allowed for the combination of two or more disability ratings, but stated that the evaluation of the same disability under various diagnoses is to be avoided.The Veterans Court affirmed the Board of Veterans’ Appeal’s denial of Perciavalle’s claim. The Federal Circuit vacated in part. The Board incorrectly interpreted Perciavalle’s CUE claim. Perciavalle’s CUE claim set forth the relevant facts and regulations. Under a sympathetic reading of that claim, the VA was required to “determine all potential claims raised by the evidence, applying all relevant laws and regulations.” View "Perciavalle v. McDonough" on Justia Law

United Therapeutics holds New Drug Application (NDA) 022387 for Tyvaso®, an inhaled solution formulation of treprostinil approved for the treatment of pulmonary hypertension. It is a vasodilator that reduces vasoconstriction in the pulmonary vasculature, thereby decreasing blood pressure. United’s patents are listed in the FDA’s Orange Book for Tyvaso. Liquidia filed NDA 213005 for Yutrepia™ (21 U.S.C. 355(b)(2)), a dry powder inhalation formulation of treprostinil that is not a generic version of any currently marketed drug. United sued Liquidia, alleging infringement. Liquidia filed a petition for inter partes review (IPR); the Board found all claims of the 793 patent unpatentable as obvious. The district court concluded that seven claims of the 793 patent were not invalid and were infringed by Liquidia; several claims of the 066 patent were invalid as anticipated and would have been infringed by Liquidia but for the finding of anticipation; and claim 8 of the 066 patent was not invalid and not infringed.The Federal Circuit affirmed, upholding the district court’s determination that the meaning of “treating pulmonary hypertension” does not require a showing of safety and efficacy; the claims of the 793 patent are adequately enabled and supported by the written description; and Liquida induced infringement of that patent. View "United Therapeutics Corp. v. Liquidia Technologies, Inc." on Justia Law

Trinity sued Covalent for infringement of patent claims relating to methods and systems for connecting users based on their answers to polling questions. The Federal Circuit affirmed the dismissal of the suit, concluding that the asserted patents do not claim patentable subject matter under 35 U.S.C. 101. Because Trinity did not identify a proposed claim construction or specific facts to be discovered, the district court was not required to conduct claim construction and fact discovery before analyzing the asserted claims. The claims are directed to the abstract idea of matching based on questioning. A human mind could review people’s answers to questions and identify matches based on those answers; the patent’s requirements that the abstract idea be performed on a “hand-held device” or that matches are “reviewable by swiping” does not alter the conclusion that the focus of the asserted claims remains directed to an abstract idea, not an improvement on technology. The claims do not provide an inventive concept by virtue of their use of multiple processors, match servers, unique identifications, or a match aggregator. View "Trinity Info Media, LLC v. Covalent, Inc." on Justia Law