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IP UPDATE
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Results for "Patent design"
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Preliminary Injunction Upheld in Cancer Relapse Detection Case

by | Jul 25, 2024 |

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including likelihood of success on the merits. The injunction included “carve outs” for patients requiring access to the affected cancer detection kits. Natera, Inc. v. NeoGenomics Laboratories, Inc. Case No. 24-1324 (Fed. Cir. July 12, 2024) (Moore, CJ; Taranto, Chen, JJ.)

Natera and NeoGenomics are both research-focused healthcare companies manufacturing products used for early detection of cancer relapse. Natera and NeoGenomics both offer products designed to identify circulating tumor DNA (ctDNA) within the bloodstream to assess the efficacy of cancer treatment and the risk of recurrence. NeoGenomics’s product is named RaDaR.

Natera owns two patents, one claiming methods for amplifying targeted genetic material, such as cfDNA, while reducing amplification of non-targeted genetic material, and the other claiming methods for detecting variations in genetic material indicative of disease or disease recurrence, such as ctDNA. Natera sued NeoGenomics, alleging that RaDaR infringed both of Natera’s patents, and moved for a PI. The district court granted the PI, finding that Natera satisfied the requirements for injunctive relief, including likelihood of success on the merits as set forth in Purdue Pharma v. Boehringer Ingelheim (Fed. Cir. 2001). The injunction barred NeoGenomics from making, using, selling, offering for sale, marketing, distributing or supplying RaDaR, with certain carve outs for patients already using RaDaR and for finalized or in-process research projects, studies and clinical trials.

To show a likelihood of success on the merits, Natera had to show that it would likely prove infringement and that its infringement claim would likely withstand challenges to the validity and enforceability of the patents. On appeal, NeoGenomics argued that the district court did not properly evaluate the likelihood of success on the merits factor because it failed to resolve a claim construction dispute and instead applied an erroneous construction.

The Federal Circuit noted that NeoGenomics first raised the erroneous claim construction issue in its motion to stay the PI pending appeal, and that neither party raised a claim construction dispute during the PI briefing. The Court therefore concluded that the district court did not abuse its discretion by not engaging in explicit claim construction before evaluating likelihood of infringement. The Federal Circuit also found that the district court did not err by implicitly construing the claims because Natera presented evidence suggesting that RaDaR’s multi-cycle polymerase chain reaction (PCR) process likely practiced the tagging and amplifying steps of the relevant claims.

NeoGenomics also argued that the district court applied an incorrect legal standard in evaluating NeoGenomics’s obviousness challenge, asserting that “mere ‘vulnerability’” of the patent to an invalidity challenge sufficed to defeat a PI. The Federal Circuit explained that the correct analysis addresses whether the patentee has shown that it is more likely than not to prevail over an invalidity challenge. The Court explained that it was not sufficient to merely allege that the individual elements of the claimed [...]

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PTO Finalizes Rules Promoting Independence in PTAB Decision-Making

by | Jun 20, 2024 |

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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No Attorneys’ Fees Available for Successful IPR in Parallel Court Proceedings

by | May 30, 2024 |

The US Court of Appeals for the Federal Circuit concluded that a party that voluntarily elects to pursue parallel proceedings before the Patent Trial & Appeal Board and the district court is not entitled to recover attorneys’ fees under 35 U.S.C. § 285 (exceptional case doctrine) in connection with the Board proceedings, nor does § 285 entitle a party to hold opposing counsel jointly and severally liable for fees. Dragon Intellectual Property LLC v. Dish Network L.L.C., Case Nos. 2022-1621; -1777; -1622; -1779 (Fed. Cir. May 20, 2024) (Moore, C.J.; Stoll, J.) (Bencivengo, J., dissenting).

Dragon sued DISH Network, Sirius XM Radio (SXM) and eight others for patent infringement. The district court stayed proceedings as to DISH and SXM while they pursued inter partes review (IPR) but proceeded with claim construction for the other defendants. Following claim construction, all parties stipulated to noninfringement, and the district court accordingly entered a noninfringement judgment that was subsequently vacated following appeal to the Federal Circuit. Following the Board’s determination that the asserted claims were unpatentable, DISH and SXM filed a motion for attorneys’ fees in the district court proceeding. The district court granted the motion for time spent litigating the district court case but denied for fees incurred solely during the IPR proceedings and recovery from Dragon’s former counsel. DISH and SXM appealed the denial-in-part, and Dragon cross-appealed the grant-in-part.

The Federal Circuit affirmed the district court’s grant-in-part, finding that the district court did not abuse its discretion in declaring these cases exceptional. The Federal Circuit explained that the vacated noninfringement judgment did not require the district court to ignore its claim construction order in determining exceptionality. The Court further explained that even though Dragon was not entitled to a claim construction “do-over,” the prosecution history disclaimer issue was independently considered during the exceptionality inquiry, and Dragon did not provide any grounds for the conclusion that this constituted an inadequate inquiry.

The Federal Circuit also affirmed the denial of attorneys’ fees with regard to fees incurred during the IPR proceedings and Dragon’s former counsel’s liability for fee awards under § 285.

First, the Federal Circuit rejected DISH and SXM’s argument that § 285 allows recovery of fees incurred during parallel IPR proceedings, principally on the grounds that the IPR proceedings were pursued voluntarily. The Court reasoned that there are many advantages to leveraging IPR proceedings and, therefore, “where a party voluntarily elects to pursue an invalidity challenge through IPR proceedings, we see no basis for awarding IPR fees under § 285.”

Second, the Federal Circuit relied on the statutory text and determined that liability for attorneys’ fees awarded under § 285 does not extend to a party’s counsel. The Court explained that while other statutes explicitly allow parties to recover costs and fees from counsel, § 285 is silent as to who can be liable for a fee award, and therefore it is reasonable to conclude that fees cannot be assessed against counsel.

Sitting by designation, Judge Bencivengo of the US District Court for the Southern District of California dissented [...]

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Getting to the Core of It: Assignment Clause Is Ambiguous

by | May 30, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s grant of summary judgment, finding that the language used in an invention assignment clause was subject to more than one reasonable interpretation (i.e., ambiguous) and thus remand was necessary for further fact finding. Core Optical Tech., LLC v. Nokia Corp., Case Nos. 23-1001; -1002; -1003 (Fed. Cir. May 21, 2024) (Dyk, Taranto, JJ.) (Meyer, J., dissenting).

Core Optical filed complaints against three groups of defendants alleging patent infringement. The lead defendant, Nokia, moved for summary judgment, arguing that Core Optical did not have standing to bring the patent infringement suit. Nokia argued that by virtue of an invention assignment clause in an employment-related agreement signed in 1990, the inventor, Dr. Core, had assigned the patent rights to TRW, his employer at the time of the invention. In the agreement, Dr. Core “agreed to disclose to TRW and automatically assign to TRW all of his inventions that ‘relate to the business or activities of TRW’ and were ‘conceived, developed, or reduced to practice’ during his employment with TRW.” Nokia argued that by virtue of that earlier assignment, the subsequent assignment to Core Optical was ineffective. The agreement had a carveout from the assignment for inventions “developed entirely on [Dr. Core’s] own time” that was unrelated to his work for TRW. According to Nokia, based on the assignment, Core Optical did not have standing to assert the patent. The district court agreed and granted Nokia’s motion for summary judgment. Core Optical appealed.

The Federal Circuit reviewed the district court’s grant of summary judgment de novo, following Ninth Circuit and California law relating to the underlying contract dispute and related factual determinations. Under California law, the “fundamental goal of contractual interpretation is to give effect to the mutual intention of the parties” (citing City of Atascadero v. MLPF&S (1998)). In granting summary judgment, the district court had held that the 1990 invention assignment agreement’s carveout did not encompass Dr. Core’s PhD research, which undisputedly led to the invention claimed in the patent. That finding was based in part on the TRW fellowship program that supported and enabled Dr. Core’s PhD work. However, Core Optical presented evidence that “Dr. Core was careful not to work on his PhD research while ‘on the clock’ at TRW and not to use TRW equipment, facilities, or supplies when working on his PhD research.”

The Federal Circuit disagreed with the district court that the matter was subject to resolution on summary judgment. The Court agreed with Core Optical that the “entirely-own-time” phrase did not unambiguously express a mutual intent to designate all the time Dr. Core spent performing his PhD research as his own time or, as Nokia argued, to indicate that some of the time Dr. Core spent performing his PhD research was partly TRW’s time (as the district court held). The Federal Circuit walked through the undisputed facts, including that Dr. Core sought funding from TRW for his PhD research and [...]

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Pay for Delay Is Sometimes Okay

by | May 23, 2024 | ,

The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a patented drug. CVS Pharmacy, Inc. v. Forest Labs. Inc., Case Nos. 23-410; -418; -420; -423 (2d Cir. May 13, 2024) (Jacobs, Sack, Nardini, JJ.)

This case involves a drug called Bystolic, which is a beta blocker designed to treat high blood pressure. Numerous purchasers of Bystolic and its generic versions brought state and federal antitrust claims against Forest Labs. and the generic manufacturers. The purchasers alleged that Forest Labs. unlawfully paid off the generic manufacturers to delay the market entry of their products and prolong Forest Labs.’ ability to reap monopoly profits. The purchasers claim that Forest Labs. covered up these payments by pretextually compensating the generics for goods and services that Forest Labs. did not truly need. The purchasers claim that without such “side deals,” generic versions of Bystolic would have entered the market earlier – whether by the generic manufacturers prevailing in the infringement litigation, entering at risk (i.e., with litigation ongoing) or agreeing to a settlement allowing for earlier market entry.

The payments made by Forest Labs. are known as “reverse payments” because, unlike a typical settlement payment, the patent holder pays the alleged patent infringer even though they have no claim for damages. In 2013, the Supreme Court explained in FTC v. Actavis that such payments should be evaluated pursuant to antitrust law’s rule of reason, under which courts balance anticompetitive effects against procompetitive benefits. The Supreme Court explained that while reverse payments may look dubious, they are not automatically unlawful. Instead, these payments may “sometimes” violate the antitrust laws, but only if they are both “large” and “unjustified.” According to the Supreme Court, whether a reverse payment passes antitrust muster “depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification,” including fair value for goods and services exchanged as part of a bona fide commercial relationship.

Forest Labs. and the generic manufacturers moved to dismiss the purchasers’ claims for failure to state a claim. The district court granted the motion, concluding that the purchasers’ allegations did not plausibly show an antitrust violation under Actavis. The purchasers’ appealed.

The Second Circuit affirmed the dismissal. Analyzing Actavis, the Court explained that reverse payments are subject to the rule-of-reason analysis and the relevant inquiry involves determining why the payment was made. The Court noted that the payments must be analyzed against a backdrop of the strong public policy favoring settlement of disputes, meaning that the payments violate antitrust law only if they are both large and unjustified or unexplainable. In turn, whether a reverse payment is “unjustified” depends on whether it “reflects traditional settlement considerations,” including “fair value” for products or services provided by the generic manufacturer pursuant [...]

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It May Be a Hairy Situation, but Detailed Declaration Sufficient Evidence of Prior Use

by | May 9, 2024 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s refusal to register a mark, finding that an unchallenged, detailed declaration by the opposing company’s director sufficed as substantial evidence of prior use. Jalmar Araujo v. Framboise Holdings, Inc., Case No. 23-1142 (Fed. Cir. Apr. 30, 2024) (Lourie, Linn, Stoll, JJ.)

On December 3, 2019, Jalmar Araujo filed an application to register #TODECACHO as a standard character mark for hair combs. Framboise Holdings filed an opposition on the grounds that Araujo’s mark would likely cause confusion with its #TODECACHO design mark (below).

Framboise Holdings alleged that it owned the mark based on its prior use of it in connection with various hair products since March 24, 2017. Framboise also filed its own application for registration of its design mark on April 14, 2020, claiming the same date of first use.

On October 18, 2021, the final day on which Framboise could submit its case in chief to the Board, it moved for a seven-day extension. Four days after filing the motion, it served Araujo with the declaration of Framboise Director Adrian Extrakt. Although it was the testimony of a single interested party, the Board found Extrakt’s declaration alone to be convincing evidence of prior use. His declaration provided a list of products and dates of first use, as well as examples of the mark displayed on products in stores. After the Board sustained the opposition, Araujo appealed.

Araujo argued that the Board abused its discretion in granting Framboise an extension of the trial period, and that the Board’s finding that Framboise established prior use of the #TODECACHO design mark was not supported by substantial evidence. The Federal Circuit disagreed.

The Federal Circuit concluded that the Board had not abused its discretion in granting Framboise an extension because it identified and applied the correct good cause standard and “reasonably found good cause to grant the extension.” The Court also found that the Board was correct in finding that Extrakt’s declaration alone was sufficient evidence to support a priority date of March 24, 2017, based on evidence of the design mark’s use in connection with various hair products. The Court noted that the declaration did not simply consist of “naked general assertions of prior use,” but contained evidence. Araujo neither deposed Extrakt nor offered any evidence to dispute his claims. Hence, Extrakt’s declaration sufficed to meet the applicable preponderance of the evidence standard.

Practice Note: Oral or written testimony, even when offered by an interested party, can establish priority of use in a trademark proceeding if it is sufficiently detailed, is supported by exhibits and is convincing.



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Cross-Appeals Fail to Strike a Chord

by | May 2, 2024 |

In the latest development in the ongoing litigation saga between competitors Sonos and Google, the US Court of Appeals for the Federal Circuit affirmed the US International Trade Commission’s determination that the original accused audio players and controllers infringed the asserted patents while redesigned products did not. Sonos, Inc. v. Int’l Trade Comm’n, Case No. 22-1421 (Fed. Cir. Apr. 8, 2024) (Stark, Dyk, Reyna, JJ.) (nonprecedential).

Sonos filed a complaint against Google at the Commission, asserting that Google’s importation of certain audio players and controllers infringed Sonos’s patents generally directed to connecting and controlling wireless speakers. The chief administrative law judge made an initial determination that Google’s originally accused products infringed each of the asserted patents but also found that Google’s redesigned products were noninfringing alternatives. After declining the parties’ petitions for review, the Commission issued a final determination adopting the chief administrative law judge’s initial determination and entered a limited exclusion order. Sonos appealed the Commission’s determination concerning the redesigned products, and Google cross-appealed the Commission’s determination concerning the original products.

Sonos argued that the Commission misconstrued disputed claim terms and lacked substantial evidence for its noninfringement findings. First, Sonos argued that the Commission misconstrued claim language reciting “at least a second message containing network configuration parameters,” which “comprise an identifier of the secure WLAN . . . and a security key.” The Commission construed this language as requiring a single second message with both the claimed identifier and security key while Sonos contended that the claim language contemplated multiple second messages that collectively contain the identifier and security key. The Federal Circuit disagreed with Sonos, noting that the specification provided strong support for the Commission’s construction. Because Google’s redesigned product transmitted the identifier and the key in separate messages, the Federal Circuit affirmed the Commission’s conclusion that Google did not infringe.

Sonos next took issue with the Commission’s determination that Google’s redesigned product, which included an incrementing integer counter for synchronizing playback among devices, did not infringe a claim requiring synchronization through “time clock information.” While Sonos framed the issue as one of claim construction, the Federal Circuit reasoned that it was actually a factual issue (whether the accused redesign infringed), which is reviewed for substantial evidence. Because Google’s experts explained that an incrementing counter does not represent a time value, the Court concluded that the Commission’s determination was supported by substantial evidence.

Finally, Sonos contested the Commission’s construction of “equalization” as requiring “alteration of the relative strength of certain frequency ranges in the audio data” by adjusting certain properties of a speaker driver, adjusting amplifier gain in a playback device or using a filter. Finding this construction too narrow, Sonos argued that “equalization” should include any modification to output audio data, including the changing of a channel output without altering strengths of a frequency range. The Federal Circuit agreed with the Commission’s construction, which was based on expert testimony and dictionaries demonstrating that “equalization” is a well-known audio technique used to enhance or diminish specific frequency ranges. [...]

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Unclean Hands Aren’t Just for Toddlers

by | Apr 25, 2024 |

In an action involving manufacturers of a self-sealing dining mat for toddlers, the US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the defendants were barred from obtaining relief on their counterclaims under the unclean hands doctrine, thereby vacating the district court’s other findings on inequitable conduct, obviousness, attorneys’ fees and costs. Luv N’ Care, Ltd. et al. v. Laurain et al., Case No. 22-1905 (Fed. Cir. Apr. 12, 2024) (Reyna, Hughes, Stark, JJ.)

Luv N’ Care and Nouri E. Hakim (collectively, LNC) filed suit against Lindsey Laurain and Eazy-PZ (EZPZ), asserting various claims for unfair competition under the Lanham Act and Louisiana law. LNC also sought declaratory judgment that EZPZ’s design patent was invalid, unenforceable and not infringed. After the suit was filed, the US Patent & Trademark Office (PTO) issued Laurain a utility patent directed toward self-sealing dining mats. Laurain subsequently assigned her rights to EZPZ, which then asserted counterclaims for utility patent, design patent and trademark infringement.

Following discovery, the district court granted LNC’s motion for summary judgment, finding all claims of EZPZ’s utility patent as obvious in view of three prior art references. EZPZ moved for reconsideration, which the district court denied, indicating that a “ruling providing further reasoning will follow in due course.” Before any such ruling issued, the PTO issued an ex parte reexamination certificate confirming the patentability of the utility patent claims two days before the district court’s bench trial began.

EZPZ did not provide this reexam certificate to the district court prior to the bench trial. During the bench trial, the district court found that EZPZ had not committed inequitable conduct but that EZPZ’s litigation conduct constituted unclean hands. After the district court entered judgment, EZPZ moved for reconsideration of summary judgment based on the ex parte reexamination certificate. The district court denied this motion and found that the evidence did not compel alteration of the prior ruling that the utility patent was invalid. It also denied LNC’s motion for attorneys’ fees and costs. EZPZ appealed.

The Federal Circuit affirmed the unclean hands determination but vacated the district court’s rulings on inequitable conduct, invalidity, attorneys’ fees and costs. As to unclean hands, the Court reasoned that EZPZ failed to disclose patent applications related to the utility patent until well after the close of discovery and dispositive motion practice. EZPZ also blocked LNC’s efforts to discover Laurain’s prior art searches by falsely claiming that she had conducted no such searches and that all responsive documents had been produced. It further found that EZPZ witnesses, including Laurain and EZPZ’s former outside counsel, repeatedly gave evasive testimony during depositions and at trial. The Court affirmed the district court’s determination that EZPZ’s misconduct bore an immediate and necessary connection to EZPZ’s claims for infringement because the undisclosed material was directly relevant to the development of LNC’s litigation strategy and undermined LNC’s ability to press its invalidity and unenforceability challenges. The Court found no clear error in the district court’s reasoning that [...]

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Sole Searching: Trade Dress Hopes Booted as Functional, Nondistinctive

by | Apr 25, 2024 |

The US Court of Appeals for the Fourth Circuit affirmed a district court’s summary judgment grant in a trademark dispute, finding that the district court did not err in concluding that a subset of design elements lacked distinctiveness in the public’s view. TBL Licensing, LLC v. Katherine Vidal, Director of the United States Patent and Trademark Office, Case No. 23-1150 (4th Cir. Apr. 15, 2024) (Quattlebaum, Gregory, Benjamin, JJ.)

TBL Licensing is commonly known as Timberland, the prominent footwear manufacturer. Timberland tried to register specific design elements of its popular boot as protected trade dress with the US Patent & Trademark Office (PTO). In its application, Timberland provided a detailed written description of the boot design elements it sought to register as protectable trade dress. Timberland also included a drawing of these design elements.

The PTO rejected Timberland’s application, finding that the design was functional and lacked distinctiveness. Timberland appealed to the Trademark Trial & Appeal Board, which affirmed. Timberland then challenged the Board’s decision in the US District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because Timberland’s design was functional and had not acquired distinctiveness. Timberland appealed.

Timberland argued that the district court improperly segmented the design during its functionality analysis. Timberland argued that the district court failed to meaningfully consider the design as a whole, and even if it did, the court erred in considering specific factors, including the availability of alternative designs and the design’s simplicity in manufacturing. The court also relied on inapposite patents and advertisements as evidence to support its functionality finding, an analysis that Timberland argued was improper.

The Fourth Circuit affirmed the district court’s decision. While acknowledging the potential error in the district court’s failure to analyze the design holistically, the Court ultimately found that the limited design elements Timberland sought to register lacked secondary meaning – a crucial element for trade dress protection. The Court employed a secondary meaning analysis to assess public perception of Timberland’s design and considered various factors, including advertising expenditures, consumer studies, sales success, unsolicited media coverage, attempts at imitation and length of exclusive use.

Applying each factor, the Fourth Circuit determined that the district court did not clearly err in finding that the design elements lacked distinctiveness. The Court explained that the district court highlighted flaws in Timberland’s consumer survey, noting suggestive questions and a lack of focus on the claimed design features. The district court also emphasized that Timberland’s advertising expenditures did not effectively link the claimed design features with Timberland in consumers’ minds. Timberland’s arguments regarding sales success, media coverage and attempts at plagiarism were also found insufficient to establish secondary meaning. Lastly, the presence of similar-looking boots from other manufacturers undermined Timberland’s claim of exclusivity in using the design.

Lacking direct consumer survey evidence, the Fourth Circuit determined that Timberland’s circumstantial evidence failed to [...]

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New Guidance Addresses Use of AI Systems, Tools in Practice Before the PTO

by | Apr 18, 2024 |

The US Patent & Trademark Office (PTO) issued new guidance on the use of artificial intelligence (AI) tools in practice before the PTO. The new guidance is designed to promote responsible use of AI tools and provide suggestions for protecting practitioners and clients from misuse or harm resulting from their use. This guidance comes on the heels of a recent memorandum to both the trademark and patent trial and appeal boards concerning the applicability of existing regulations addressing potential misuse of AI  and recent guidance addressing the use of AI in the context of inventorship.

Patent practitioners are increasingly using AI-based systems and tools to research prior art, automate the patent application review process, assist with claim charting, document reviews and gain insight into examiner behavior. The PTO’s support for AI use is reflected in patent examiners’ utilization of several different AI-enabled tools for conducting prior art searches. However, because AI tools are not perfect, patent practitioners are potentially vulnerable to misuse or misconduct. Therefore, the PTO’s new guidance discusses the legal and ethical implications of AI use in the patent system and provides guidelines for mitigating the risks presented by AI tools.

The guidance discusses the PTO’s existing rules and policies for consideration when applying AI tools, including duty of candor, signature requirement and corresponding certifications, confidentiality of information, foreign filing licenses and export regulations, electronic systems’ policies and duties owed to clients. The guidance also discusses the applicability of these rules and policies with respect to the use of AI tools in the context of document drafting, submissions, and correspondence with the PTO; filing documents with the PTO; accessing PTO IT systems; confidentiality and national security; and fraud and intentional misconduct.

AI tools have been developed for the intellectual property industry to facilitate drafting technical specifications, generating responses to PTO office actions, writing and responding to briefs, and drafting patent claims. While the use of these tools is not prohibited, nor is there any obligation to disclose their use unless specifically requested, the guidance emphasizes the need for patent practitioners to carefully review any AI outputs generated before signing off on any documents or statements made to the PTO. For example, when using AI tools, practitioners should make a reasonable inquiry to confirm that all facts presented have evidentiary support, that all citations to case law and other references are accurately presented, and that all arguments are legally warranted. Any errors or omissions generated by AI in the document must be corrected. Likewise, trademark and Board submissions generated or assisted by AI must be reviewed to ensure that all facts and statements are accurate and have evidentiary support.

While AI tools can be used to assist or automate the preparation and filing of documents with the PTO, care must be taken to ensure that no PTO rules or policies are violated and that documents are reviewed and signed by a person, not an AI tool or non-natural person. AI [...]

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