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Bayou Jambalaya: Sanction Motions, Motions to Vacate and Trade Dress Injunctions

The US Court of Appeals for the Fifth Circuit issued a three-part ruling that affirmed the district court’s denial of a motion to vacate as void the judgment based on Rooker-Feldman doctrine because the earlier state and district court decisions were not “inextricably intertwined,” affirmed the district court’s permanent injunction because the district court based it on the Fifth Circuit’s prior decision, and affirmed the denial of a motion for Rule 11 sanctions because the filed motion was different from the Rule-11-mandated notice that was originally served. Uptown Grill, L.L.C. v. Camellia Grill Holdings, Inc., Case No. 21-30639 (5th Cir. Aug. 23, 2022) (Higginbotham, Higginson, Oldham, JJ.)

This dispute arises from three agreements between Uptown Grill and Camellia Grill: the “Cash Sale, the Bill of Sale and the License Agreement. The Cash Sale and Bill of Sale transferred property from Camellia Grill to Uptown Grill. The License Agreement granted a license to Uptown Grill to use certain trademarks and trade dress. In 2011, Camellia Grill sued Uptown Grill for breach of the License Agreement in state court. The state court found that the appellee breached the license and restored to the appellant all rights to the marks. The court did not, however, construe the Bill of Sale.

While the state court litigation was on appeal, Camellia Grill sued Uptown Grill in federal court for trademark infringement. The district court found that the Bill of Sale transferred the trademarks to Uptown Grill before execution of the License Agreement, and therefore found that Camellia Grill’s infringement claim failed. However, the district court also found that the License Agreement limited Uptown Grill’s use of the trade dress to a single restaurant, and the court issued an injunction to that effect. The Fifth Circuit affirmed these findings in a 2019 decision in Uptown Grill, LLC v. Camellia Grill Holdings, Inc., but remanded the issue of whether Uptown Grill’s use of the Camellia grill trade dress at the new restaurant location constituted a breach of the License Agreement.

On remand, Camellia Grill moved for summary judgment that Uptown Grill breached the License Agreement by using the Camellia Grill trade dress after the termination of the License Agreement. Uptown Grill moved for partial summary judgment on the trade dress injunctions, arguing that Camellia Grill lacked standing since Uptown Grill was not using any trade dress at any new locations. Camellia Grill also filed a motion to dismiss for lack of jurisdiction under the Rooker-Feldman doctrine, under which “inferior federal courts do not have the power to modify or reverse state court judgments’ except when authorized by Congress.” Finally, Uptown Grill moved for sanctions against Camellia Grill for “abusive and harassing conduct.” The district court denied both Camellia Grill’s motion to dismiss for lack of jurisdiction and Uptown Grill’s motion for sanctions. The district court determined that Uptown Grill had breached the License Agreement’s post-termination provisions. The court also decided that the trade dress elements should be limited to that which is protectable under [...]

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Yes, and It Counts! Single Purchase in Forum Establishes Personal Jurisdiction over Infringer

The US Court of Appeals for the Seventh Circuit affirmed exercise of personal jurisdiction over a foreign online retailer for a trademark infringement claim where the trademark owner purchased the only allegedly infringing article sold in the forum. NBA Properties, Inc. v. HANWJH, Case No. 21-2909 (7th Cir. Aug. 16, 2022) (Ripple, Scudder, JJ.)

NBA Properties owns the trademarks for the National Basketball Association (NBA) and NBA teams. HANWJH is a China-based online retailer that sells allegedly infringing NBA branded products on a well-known e-commerce site. HANWJH offered 205 allegedly infringing products that were available for purchase in Illinois, the forum state. HANWJH’s only online order in Illinois was made by an investigator for NBA Properties who purchased a pair of basketball shorts for delivery to an Illinois address. The shorts were delivered to the Illinois address before NBA Properties filed suit against HANWJH.

NBA Properties sued HANWJH for trademark infringement and counterfeiting under 15 U.S.C. § 1114 and false designation of origin under 15 U.S.C. § 1125(a) in the Northern District of Illinois. NBA Properties sought and received a temporary restraining order and preliminary injunction, including a temporary asset restraint on HANWJH’s bank account. After HANWJH failed to timely answer the complaint, NBA Properties moved for default judgment. HANWJH moved to dismiss the case for lack of personal jurisdiction, arguing the following:

  • Operating a website is not sufficient on its own to establish personal jurisdiction.
  • A single transaction by the plaintiff cannot support the exercise of personal jurisdiction.
  • Even if the exercise of personal jurisdiction were otherwise appropriate, such exercise would offend the traditional notions of fair play and substantial justice.

The district court denied HANWJH’s motion to dismiss and entered a default. HANWJH failed to object to the motion for default judgment, and the district court entered a final judgment. HANWJH appealed.

The Seventh Circuit reviewed the “minimum contacts” International Shoe criterion before turning to a more recent line of cases applying this standard to online retailers. Citing its 2020 decision in Curry v. Revolution Laboratories, the Court noted that the minimum contacts requirement is satisfied if “the defendant reasonably could foresee that its product would be sold in the forum.” The Court reasoned that allowing customers to order products from a website to the forum and then fulfilling an order to the forum can form the basis of personal jurisdiction—even when the only orders to the forum were made by the plaintiff, as long as the orders were made before filing suit. Applying these principles, the Court found that HANWJH had purposefully directed conduct at Illinois by establishing an online store, demonstrating a willingness and capacity to ship goods to Illinois and intentionally shipping an infringing product to an Illinois address. The Court explained that it was irrelevant that only a single allegedly infringing article was sold in Illinois and that it was purchased by the plaintiff, because the proper focus of the analysis was on HANWJH’s purposeful conduct. The Court also concluded that HANWJH’s [...]

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Claim Cancelation Limits but Doesn’t Prohibit Assignor Estoppel Defense

On remand from the Supreme Court, the US Court of Appeals for the Federal Circuit reconsidered the boundaries of the doctrine of assignor estoppel. The Federal Circuit found that the patent assignor was estopped from challenging the validity of an asserted patent because the asserted claim was not materially broader than the specific claims assigned to the patent owner. Hologic, Inc. v. Minerva Surgical, Inc., Case Nos. 2019-2054; -2081 (Fed. Cir. Aug. 11, 2022) (Stoll, Clevenger, Wallach, JJ.)

Csaba Truckai filed a patent application for a device that was designed with a moisture-permeable head to treat abnormal uterine bleeding while avoiding unintended burning or ablation. Truckai assigned the pending patent application to his company, Novacept, which was later acquired by Hologic. Truckai then founded a new company, Minerva Surgical, and developed a new device that used moisture impermeability to avoid the unwanted ablation. Hologic subsequently filed a continuation application to expand the scope of its claims to encompass applicator heads in general, regardless of moisture permeability. The US Patent & Trademark Office issued a patent on the expanded claims in 2015, and Hologic subsequently sued Minerva for patent infringement.

Hologic argued that doctrine of assignor estoppel barred Minerva from challenging the validity of the patent claims. The district court agreed and granted summary judgment of infringement. On appeal, the Federal Circuit affirmed the summary judgment of no invalidity. The Supreme Court granted certiorari and declined Minerva’s request to discard the doctrine of assignor estoppel but clarified that it comes with limits, holding that “assignor estoppel applies only when an inventor says one thing (explicitly or implicitly) in assigning a patent and the opposite in litigation against the patent’s owner.” The Supreme Court remanded to the Federal Circuit to address whether Hologic’s claim was materially broader than the one Truckai assigned. The Supreme Court explained that if the asserted claim was materially broader than the assigned claim, “then Truckai could not have warranted its validity in making the assignment and without such a prior inconsistent representation, there is no basis for estoppel.”

On remand, the Federal Circuit considered whether Truckai warranted the assigned claim’s validity at the time of assignment and whether the assigned claim was materially broader than the asserted claim.

The Federal Circuit concluded that Truckai had represented that the assigned claim was valid. The Court explained that the assigned claim was initially rejected as being anticipated, but Truckai successfully argued for its allowance. The claim was then canceled in response to a restriction requirement, but such cancellation did not speak to the claim’s patentability because an assignee would understand that it could later prosecute the claim’s subject matter under standard patent practice. Therefore, cancelation did not nullify the claim, and it “remained viable for further prosecution.” Additionally, the assignment was not just to the rights to the application, but to the rights to any continuation, continuation-in-part or divisional patent applications not yet filed. When presenting the application, Truckai signed [...]

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Not “Use It or Lose It”: Even if Unexercised, Director’s Authority over Institution Decisions Remains

The US Court of Appeals for the Federal Circuit denied mandamus relief, finding that a party is not entitled to petition the director for review of a Patent Trial & Appeal Board (Board) decision denying institution of an inter partes review (IPR) or post-grant review (PGR) proceeding. This ruling reflects the Court’s ongoing consideration of the Supreme Court’s decision in United States v. Arthrex, Inc., which held that Board judges cannot constitutionally render final decisions in IPRs without US Patent & Trademark Office (PTO) Director oversight. Click here for our discussion of the case on remand, for which the Federal Circuit just denied en banc rehearing. In re Palo Alto Networks, Inc., Case No. 22-145 (Fed. Cir. Aug. 16, 2022) (Dyk, Chen, JJ.) (Reyna, J., concurring).

After being sued by Centripetal Systems for patent infringement, Palo Alto Networks filed petitions for IPR and PGR of some of the asserted patents. The Board denied institution, and Palo Alto Networks filed requests for Director rehearing. Although the PTO acknowledged receipt of the request, it informed Palo Alto Networks that the Director was not considering requests for rehearing of institution decisions “at this time.” Thereafter, Palo Alto Networks sought a writ of mandamus from the Federal Circuit. Between the request for mandamus and the Court’s decision, the PTO issued guidance explaining that although the PTO was not considering requests for rehearing, “the Director has always retained and continues to retain the authority to review such decisions sua sponte after issuance (at the Director’s discretion),” and indeed, exercised its authority to initiate sua sponte review since.

The Federal Circuit rejected Palo Alto Networks’ claim that the Director’s refusal to consider petitions for rehearing of institution decisions amounted to an abdication of authority prohibited by the Appointments Clause. Even assuming that institution decisions were “final decisions on how to exercise executive power” implicating the Appointments Clause, the Court found that the Director maintains statutory and regulatory authority to review institution decisions (unlike in Arthrex), and that the Board renders such decisions only based on the Director’s delegation of authority (also unlike Arthrex). Accordingly, the structural authority maintained by the Director is sufficient, even if such authority goes unexercised, according to the Court.

Writing separately, Judge Reyna agreed that no Appointments Clause violation had occurred but on different grounds. Although Judge Reyna noted that a categorical rejection of requests for rehearing by the Director might raise constitutional concerns, he concluded that mandamus was inappropriate for several reasons. First, the Director’s caveat that she refused to accept requests “at this time” did not constitute a categorical refusal but rather an exercise of discretion. Second, the Director’s invocation of her sua sponte authority to review belied a lack of exercise of discretion. The Director did in fact exercise sua sponte authority to consider Palo Alto Networks’ request, even though briefing in the Federal Circuit was pending, and thus a writ of mandamus was inappropriate.




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Seal of Disapproval: TTAB Refuses Registration of County Logos

The Trademark Trial & Appeal Board (Board) issued a precedential decision affirming the US Patent & Trademark Office (PTO) Examining Attorney’s refusal to register two different logo marks filed by southern California’s County of Orange because the marks consisted of and comprised, respectively, an insignia of a municipality. The Board found that a logo adopted by a government entity does not have to be “official” to constitute an insignia for which trademark registration is prohibited under Section 2(b) of the Trademark Act, 15 U.S.C. §1052(b). In re County of Orange, Ser. Nos. 87419378; 87639750 (TTAB, Aug. 4, 2022) (Shaw, Coggins, Allard, Administrative Trademark Judges).

The County applied to register two logo marks. The US trademark applications described one mark as “a circle with the image of three oranges in front of an orange grove and . . . mountains with the words ‘COUNTY OF ORANGE’ . . . and . . . ‘CALIFORNIA’ . . . [around] the circle” (Circle Mark). The second logo mark featured a park ranger badge design that encompassed the Circle Mark in its entirety.

The PTO examining attorney refused registration of both logo marks under Section 2(b), which imposes an absolute bar on registration on either the Principal or Supplemental Register of a mark that “[c]onsists of or comprises the flag or coat of arms or other insignia of the United States, or of any State or municipality, or of any foreign nation, or any simulation thereof.”. This section reflects the sentiment that such symbols are indicia of government authority that ought to be reserved solely for signifying the government, and which should not be registered as symbols of origin for commercial goods and services.

On appeal to the Board, the County argued that the logo marks did not constitute “insignia” because they were not an “official” seal of the County, and, even if they were, registration should not be precluded because the County is not a “municipality.” Considering both of these arguments in turn, the Board provided analysis specific to both the circle and badge iterations of the applied-for logos.

The County argued first that the proposed marks could not constitute an insignia of Orange County, California, because the County created and adopted an official seal (a design of an orange having a stem with three leaves) more than a century ago, in accordance with the applicable state government code requiring a two-step process for adopting an official seal.

The Board found this argument unpersuasive, noting that although the Circle Mark had not undergone the state’s two-step process to become an “official” seal, Section 2(b) does not distinguish between “official” and “unofficial” insignia. Therefore, formal adoption of an “official” seal is not required for an insignia to otherwise fall under the Section 2(b) bar to registration.

The Board explained that the County uses the Circle Mark for a plethora of official government business [...]

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Single T-Shirt Sale Can’t Clothe Bare-Bones Personal Jurisdiction Claim

The US Court of Appeals for the Eighth Circuit affirmed a district court’s dismissal of a trademark infringement suit for lack of personal jurisdiction, finding that the trademark owner failed to allege that the alleged infringer could reasonably anticipate being hauled into court in Missouri. Brothers and Sisters in Christ, LLC v. Zazzle, Inc., Case No. 21-1917 (8th Cir. Aug. 2, 2022) (Smith, Benton, Kelly, JJ.)

Brothers and Sisters in Christ (BASIC) is a Missouri-based clothing company that owns the trademark “love happens.” Zazzle is a California-based online retailer. BASIC sued Zazzle in a Missouri district court for trademark infringement, alleging that Zazzle used its nationally available website to advertise and sell goods in Missouri. BASIC further alleged that in 2019, Zazzle sold and shipped a t-shirt bearing a purportedly infringing “love happens” logo to at least one Missouri resident. The district court granted Zazzle’s motion to dismiss for lack of personal jurisdiction under Fed. R. Civ. P. 12(b)(2). BASIC appealed.

Reviewing the issue de novo, the Eighth Circuit affirmed the dismissal. The Court explained that because the Lanham Act does not authorize nationwide personal jurisdiction, the Court was required to apply Missouri’s long-arm statute and the federal due process clause. Given that Missouri’s long-arm statute authorizes personal jurisdiction over defendants who engage in, among other things, the transaction of any business or the commission of a tortious act within the state, the Court’s inquiry focused on whether exercising personal jurisdiction over Zazzle comported with the due process clause. Because BASIC did not allege that Zazzle was subject to general personal jurisdiction in Missouri (i.e., BASIC did not allege that Zazzle was “essentially at home” in the forum state), the question instead turned on whether BASIC had sufficiently pled facts to support a claim of specific personal jurisdiction.

The Eighth Circuit explained that specific personal jurisdiction existed over Zazzle for the purposes of BASIC’s trademark infringement claims if Zazzle had certain minimum contacts with the forum state and BASIC’s claims arose out of or related to those contacts. For specific jurisdiction to apply, the underlying controversy must be connected to the defendant’s activities in the forum state; unconnected activities directed to the forum state, no matter how numerous or systematic, cannot convey specific personal jurisdiction. The Court used a five-factor test previously set forth in Whaley v. Esebag to conduct its analysis: “(1) the nature and quality of [defendant’s] contacts with the forum state; (2) the quantity of such contacts; (3) the relation of the cause of action to the contacts; (4) the interest of the forum state in providing a forum for its residents; and (5) convenience of the parties.”

The Eighth Circuit found that the behavior alleged by BASIC (Zazzle’s operation of a national website that sells and ships goods to Missouri combined with a single specific instance of an allegedly infringing t-shirt being sold and shipped to a Missouri consumer) was insufficient to support a specific jurisdiction claim. Zazzle’s website availability and sales unrelated to the use [...]

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Too Little Too Late: No Tenable Misappropriation Claim Based on 11-Year-Old Prototype

In a dispute between an employer and a former employee, the US Court of Appeals for the Seventh Circuit affirmed a district court’s grant of summary judgment against an employer asserting trade secret misappropriation and breach of implied-in-fact contract claims relating to an 11-year-old prototype developed by a former employee. The Court also affirmed the district court’s finding of litigation misconduct by the former employer but vacated the lower court’s award of attorneys’ fees, remanding the case for a more detailed justification for the considerable award. REXA, Inc. v. Chester, Case Nos. 20-2953; -3213; -2033 (7th Cir. July 28, 2022) (Wood, Hamilton, Brennan, JJ.)

Mark Chester is a former employee of Koso America, a manufacturer of hydraulic actuators. Chester participated in a 2002 project at Koso that sought to develop a new flow matching valve for Koso’s actuators. While the project team failed to design a new flow matching valve, they did manage to develop an experimental prototype of an actuator with solenoid valves. Koso abandoned the new design because of the improbability of commercial success, and the prototype was disassembled. Chester—who had never signed a confidentiality or employment agreement with Koso—resigned from Koso in 2003 and later joined MEA Inc. in 2012. In 2013, 11 years after developing the Koso prototype, Chester helped MEA design a new actuator with solenoid valves and an improved motor. MEA filed a patent application in 2017 claiming the actuator, and the US Patent & Trademark Office issued a notice of allowance in 2018 based on the improved motor limitations.

REXA, a successor company to Koso, sued Chester and MEA for misappropriation under the Illinois Trade Secrets Act (ITSA) and for breach of an implied-in-fact contract. REXA alleged that MEA and Chester misappropriated the 2002 designs by filing the 2017 patent application and by incorporating the 2002 designs into MEA’s Hawk brand actuator, and that Chester breached an implied-in-fact obligation to assign any patent rights associated with the 2017 application to REXA. Chester and MEA accused REXA of improper conduct during discovery after REXA appended a confidentiality agreement that Chester had never received to Chester’s 2002 bonus letter and used the manipulated document during Chester’s deposition. The parties filed cross motions for summary judgment. The district court ruled for Chester and MEA and awarded them almost $2.4 million in attorneys’ fees for REXA’s litigation misconduct. REXA appealed.

Misappropriation of Trade Secrets

The Seventh Circuit first considered the trade secret misappropriation claim, specifically whether REXA had identified a trade secret with enough specificity. The ITSA requires that a plaintiff “present a specific element, or combination of elements, that is unknown to the trade and was allegedly misappropriated.” Applying this standard, the Court found that REXA had not identified any protectable trade secrets because it had broadly asserted that the “2002 designs” qualified as trade secrets without explicitly identifying an element that was not well known in the industry.

The Seventh Circuit further concluded that even if REXA had identified a specific and protectable trade secret, [...]

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Rage against the Machine: Inventors Must Be Human

The US Court of Appeals for the Federal Circuit found that an artificial intelligence (AI) software system cannot be listed as an inventor on a patent application because the Patent Act requires an “inventor” to be a natural person. Thaler v. Vidal, Case No. 21-2347 (Fed. Cir. Aug. 5, 2022) (Moore, Taranto, Stark, JJ.)

Stephen Thaler develops and runs AI systems that generate patentable inventions, including a system that he calls his “Device for the Autonomous Bootstrapping of Unified Science” (DABUS). In 2019, Thaler sought patent protection for two of DABUS’s putative inventions by filing patent applications with the US Patent & Trademark Office (PTO). Thaler listed DABUS as the sole inventor on both applications. The PTO found that the patent applications lacked valid inventorship and sent a Notice of Missing Parts requesting that Thaler identify a valid inventor. Thaler petitioned the director to vacate the notices. The PTO denied the petitions, explaining that a machine does not qualify as an inventor and that inventors on patent applications must be natural persons. Thaler then pursued judicial review in the district court. The district court agreed with the PTO, concluding that an “inventor” under the Patent Act must be an “individual,” and that the plain meaning of “individual” is a natural person. Thaler appealed.

The sole issue on appeal was whether an AI software system can be an “inventor” under the Patent Act. The Federal Circuit started with the statutory language of the Patent Act, finding that it expressly provides that inventors are “individuals.” The Court noted that while the Patent Act does not define “individual,” the Supreme Court has explained that the term “individual” refers to a human being unless there is some indication that Congress intended a different reading. The Federal Circuit also found that this result was consistent with its own precedent, which found that neither corporations nor sovereigns can be inventors; instead only natural persons can be inventors.

The Federal Circuit rejected Thaler’s policy argument that inventions generated by AI should be patentable to encourage innovation and public disclosure. The Court found that these policy arguments were speculative, lacked any basis in the text of the Patent Act, and were contrary to the unambiguous text of the Patent Act. The Court also rejected Thaler’s reliance on the fact that South Africa has granted a patent with DABUS as an inventor, explaining that the South African Patent Office was not interpreting the US Patent Act. The Court concluded that since Congress has determined that only a natural person can be an inventor, AI cannot be an inventor.

Practice Note: The Federal Circuit’s decision comes on the heels of a decision from the US Copyright Office Review Board finding that a work must be created by a human being to obtain a copyright. The Federal Circuit also noted that it was not confronted with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.




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Don’t Dew It: Second Circuit Cans Likelihood of Confusion Argument

The US Court of Appeals for the Second Circuit reversed and vacated a district court’s preliminary injunction grant because the district court erred in assessing the strength of a trademark. RiseandShine Corporation v. PepsiCo, Inc., Case No. 21-2786 (2d Cir. July 22, 2022) (Leval, Chin, Menashi, JJ.)

Rise Brewing began selling canned coffee under the registered mark “RISE” in 2016. The registered mark consists of the word “rise” in large, red, regular capital letters with the words “Brewing Co.” below in a smaller, similar font on a horizontal line. The mark appears on every bottle of Rise Brewing’s canned coffee products.

In March 2021, PepsiCo launched a canned energy drink product under the mark “MTN DEW RISE ENERGY,” which contains the word “rise” on the top of each can, followed by the word “energy” running vertically up its side in a much smaller font and the MTN DEW house mark above the word “rise.”

Rise Brewing filed a complaint for trademark infringement and filed a motion for a preliminary injunction to enjoin PepsiCo from using or displaying the challenged in the market pending trial. The district court granted the motion, finding that Rise Brewing was likely to succeed on the merits regarding likelihood of confusion. PepsiCo appealed.

The Second Circuit explained that the party seeking a preliminary injunction over the use of a trademark can meet the likelihood of success prong of the preliminary injunction standard by showing that a significant number of consumers are likely to be misled or confused as to the source of the products in question. Here, the district court found that there would be a likelihood of reverse confusion—that consumers would mistake Rise Brewing’s coffee products (the prior user) as Mountain Dew products (the subsequent user). The Court disagreed and reversed, finding that the district court erred in the evaluation of the most important factor: strength of the mark.

The strength of a trademark is assessed based on either or both of two components:

  1. The degree to which it is inherently distinctive
  2. The degree to which it has achieved public recognition in the marketplace.

Although the Second Circuit agreed with the district court that the RISE trademark was a suggestive mark, it disagreed on the extent to which it was distinctive. The Court explained that “[t]he district court failed to note that the strong logical associations between ‘Rise’ and coffee represent weakness and place the mark at the low end of the spectrum of suggestive marks.” Because of the legal element in determination of the strength of a given mark, the district court’s mistake constituted a legal error.

The Second Circuit found that the lack of distinctiveness in using the term “rise” to describe coffee products can [...]

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PTO Issues Notice on Duties of Disclosure and Reasonable Inquiry

The US Patent & Trademark Office (PTO) issued a notice on July 29, 2022, titled “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board.” The notice comes in response to US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and to a September 9, 2021, letter from Senators Patrick Leahy (D-VT) and Thom Tillis (R-NC), who requested that the PTO “take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [PTO] and other federal agencies.”

PTO Director Vidal explained in the notice that parties involved in proceedings before the PTO should not take a position about the patentability of the claims that is inconsistent with positions taken in submissions to other government agencies regarding the same subject matter. If a party to a PTO proceeding discovers that an earlier position taken in a submission to the PTO or another government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record.

When an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other government agencies, such as the US Food & Drug Administration (FDA).

Any party presenting a paper to the PTO has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise a review of documents that are submitted to or received from other government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the PTO, the party has a duty to submit the information to the PTO.

Each individual with a duty to disclose, or each party with a duty of reasonable inquiry, should ensure that statements made to the PTO and other government agencies, or any statements made on their behalf to other government agencies regarding the claimed subject matter, are consistent. Providing material information to other government agencies, including the FDA, while simultaneously withholding the same information from the PTO violates those duties.

Further, any individual with a duty to disclose, or any party with a duty of reasonable inquiry, should review documents it receives from other government agencies to determine whether the information should be submitted to the PTO. For example, a party receiving a paragraph IV certification related to a generic drug application (e.g., an Abbreviated New Drug Application (ANDA)) should review such documents to determine whether they are material to the patentability of any pending matters before the PTO. If any information that is part of the ANDA process is deemed material to patentability in a pending PTO matter, then such [...]

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