On April 29, 2024, the Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) released guidance to federal contractors regarding the use of artificial intelligence (AI) in their employment practices. Seehttps://www.dol.gov/agencies/ofccp/ai/ai-eeo-guide. The guidance reminds federal contractors of their existing legal obligations, the potentially harmful effects of AI on employment decisions if used improperly, and best practices. Arriving early, the guidance puts contractors on notice of their responsibilities when using AI in their employment decisions.On October 30, 2023, President Joe Biden issued Executive Order (EO) 14110, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. 88 Fed. Reg. 75191 (Nov. 1, 2023). Recognizing that AI “holds…both promise and peril,” the EO establishes a policy framework for a coordinated federal governmentwide approach to developing and using AI that is responsible, safe, and secure. Section 7.3 directed the secretary of labor to “publish guidance for Federal contractors regarding nondiscrimination in hiring involving AI and other technology-based hiring systems” no later than October 30, 2024. 88 Fed. Reg. at 75213.The OFCCP guidance focuses primarily on the use of AI in equal employment opportunity (EEO) activities and applies to both federal prime contractors and subcontractors (collectively, federal contractors). The guidance consists of two parts: (1) common questions asked about the use of AI in EEO activities and (2) best practices federal contractors should consider when using AI in EEO activities.Echoing sentiments similarly advocated in EO 14110, the OFCCP guidance notes that AI has the potential to increase efficiency and employment decision-making w

(A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action”).[v] U.S. Federal Food and Drug Administration: Software as a Medical Device.[vi] Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, October 30, 2023.[vii] FDA: Software as a Medical Device (SaMD) (We note that the definition follows the International Medical Device Regulators Forum).[viii] Health IT: The Office of the National Coordinator for Health Information Technology Clinical Decision Support; AI for Health Care Providers: Overview, Practical Law Practice Note Overview, Westlaw, Thomson Reuters, w-025-7755, 2024.[ix] White House Office of Science and Technology Policy, Blueprint for An AI Bill of Rights, October 2022.[x] Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, October 30, 2023; 88 Fed. Reg. 75191, November 1, 2023.[xi] White House Briefing: Delivering on the Promise of AI to Improve Health Outcomes, December 14, 2023 (Payor and provider commitments include: Allina Health, Bassett Healthcare Network, Boston Children’s Hospital, Curai Health, CVS Health, Devoted Health, Duke Health, Emory Healthcare, Endeavor Health, Fairview Health Systems, Geisinger, Hackensack Meridian, HealthFirst (Florida), Houston Methodist, John Muir Health, Keck Medicine, Main Line Health, Mass General Brigham, Medical University of South Carolina Health, Oscar, OSF HealthCare, Premera Blue Cross, Rush University System for Health, Sanford Health, Tufts Medicine, UC San Diego Health, UC Davis Health, and WellSpan Health).[xii] 89 Fed. Reg. 37522 (May 6, 2024), https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08711.pdf.[xiii] Federal Trade Commission, Department of Labor, Department of Justice, Consumer Financial Protection Bureau, Department of Education, Department of Homeland Security, Depart

aneous invention, unexpected results, copying, etc.?How does the recency of the information used to train an AI model impact the PHOSITA assessment when the assessment may be focused on an earlier time?How does the availability of AI to a PHOSITA impact enablement?Section IV.C: USPTO Guidance and Legislative ConsiderationsWhat guidance on these questions from the USPTO would be helpful?In what other ways does the proliferation of AI impact patentability?Are there any laws or practices in other countries that address these questions?Should title 35 of the U.S. Code be amended, and why?See Request for Comments Regarding the Impact of the Proliferation of Artificial Intelligence on Prior Art, the Knowledge of a Person Having Ordinary Skill in the Art, and Determinations of Patentability Made in View of the Foregoing, 89 FR 34217 (Apr. 30, 2024) [hereinafter RFC].Id. Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, Executive Order 14110, 88 FR 75191 (Nov. 1, 2023). Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. 10043-51 (Feb. 13, 2024).Id. RFC at 34218-19; see also MPEP 2128.I; In re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981). RFC at 34219. RFC at 34219; see also MPEP 2121. RFC at 34219; 35 U.S.C. 103. RFC at 34219; Graham v. John Deere Co., 383 U.S. 1, 17 (1966). RFC at 34219; In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). RFC at 34219.Id. at 34219-20.Id. at 34220.Id. at 34219-20.Id. at 34220.Id.[View source.]

1207 (Fed. Cir. 2022) established that only a human inventor—not an AI system—can be validly named as an inventor on a U.S. patent application. Thus, under Thaler, inventions that are invented entirely by AI systems are not eligible for U.S. patent protection. However, the Thaler court explicitly acknowledged that its decision did not confront the more nuanced question of “whether inventions made with the assistance of AI are eligible for patent protection.” Thaler v. Vidal, 43 F.4th at 1213.Following the Thaler decision, the Biden administration’s AI Executive Order directed the USPTO director to weigh in on the very issue flagged as unresolved by the Thaler court. The AI Executive Order of Nov. 1, 2023, charged the USPTO director to “publish guidance to USPTO patent examiners and applicants addressing inventorship and the use of AI, including generative AI, in the inventive process.” Executive Order 14110, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,88 Fed. Reg. 75191-75226 (Nov. 1, 2023).The USPTO has now issued that guidance (Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. 10043-10051 (Feb. 13, 2024)) and is seeking public comment on it for a 90-day period.USPTO Position: Significant Human Contribution to Conception Is RequiredThe standard endorsed by the USPTO in its guidance for AI-assisted inventions is the following: “While AI systems . . . cannot be listed as inventors on patent applications or patents, the use of an AI system by a natural person(s) does not preclude a natural person(s) from qualifying as an inventor (or joint inventors) if the natural person(s) significantly contributed to the claimed invention.” 89 Fed. Reg. at 10046. Critically, significant contribution to an invention requires significant contribution to the conception of the invention. Traditionally, conception is defined as the formation of an invention in the mind of an inventor. Conception is distinct from reduction to practice, which involves the processes of actual const

question of unpatentability for improper inventorship (e.g., whether a human “significantly contributed” to be properly named as an inventor), then applicants must disclose that information to the USPTO. Likewise, the duty of reasonable inquiry remains unchanged but can require practitioners to investigate the extent to which AI tools were used to create the invention.The inventorship of AI-assisted inventions and the copyright protection of AI-generated works are two of the most pressing legal questions surrounding AI. Recent developments in both areas highlight the complexities and uncertainties that AI poses to existing legal frameworks. The AI EO directed the USPTO to publish additional guidance on the patent eligibility of AI innovations later this year. The USPTO is hosting a webinar covering the Guidance on March 5, 2024, and is accepting public comments on the Guidance through May 13, 2024.Akin previously covered the United States Copyright Office’s position here. Exec. Order No. 14110, 88 Fed. Reg. 75191 (Nov. 1, 2023), https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/. The Guidance was released on February 12 and published in the Federal Register on February 13. USPTO issues inventorship guidance and examples for AI-Assisted Inventions, UNITED STATES PATENT AND TRADEMARK OFFICE (Feb. 12, 2024), https://www.uspto.gov/subscription-center/2024/uspto-issues-inventorship-guidance-and-examples-ai-assisted-inventions; Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. 10043 (Feb. 13, 2024), https://www.federalregister.gov/documents/2024/02/13/2024-02623/inventorship-guidance-for-ai-assisted-inventions. Note that the Guidance is not substantive rulemaking, but instead sets policy interpreting how existing law applies. The Guidance applies to utility, design, and plant patents. Inventorship Guidance for AI-Assisted Inventions, 89 Fed. Reg. at 10045, 10049.Thaler v. Vidal, 43

eg. 5698 (Jan. 29, 2024), https://www.federalregister.gov/documents/2024/01/29/2024-01580/taking-additional-steps-to-address-the-national-emergency-with-respect-to-significant-malicious.2 For additional information, please see our alerts on the ICTS Supply Chain regulatory framework (here) and (here) and on the Cybersecurity Executive Order (here) and (here).3What is IaaS?, GOOGLE, https://cloud.google.com/learn/what-is-iaas. The proposal would define IaaS as “any product or service offered to a consumer, including complimentary or ‘trial’ offerings, that provides processing, storage, networks, or other fundamental computing resources, and with which the consumer is able to deploy and run software that is not predefined, including operating systems and applications.”4 E.O. 13984, 86 Fed. Reg. 6837 (Jan. 25, 2021), https://www.federalregister.gov/documents/2021/01/25/2021-01714/taking-additional-steps-to-address-the-national-emergency-with-respect-to-significant-malicious.5 E.O. 14110, 88 Fed. Reg. 75191 (Nov. 1, 2023), https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence.6Codified at 31 U.S.C. § 5318(l).7 68 Fed. Reg. 25,090 (May 9, 2003), https://www.federalregister.gov/documents/2003/05/09/03-11019/customer-identification-programs-for-banks-savings-associations-credit-unions-and-certain.8Assessing Compliance with BSA Regulatory Requirements, FFIEC, https://bsaaml.ffiec.gov/manual/AssessingComplianceWithBSARegulatoryRequirements/01.9 31 C.F.R. § 1020.220(a)(2)(i)(A)(3). For an individual: a residential or business street address, or if the individual does not have such an address, an Army Post Office (APO) or Fleet Post Office (FPO) box number, or the residential or business street address of next of kin or of another contact individual. For a “person” other than an individual (such as a corporation, partnership, or trust): a principal place of business, local office, or other physical location.10 An identificati

noting that “existing requirements and guidance may apply to AI.”14 In SEC Chair Gary Gensler’s comments to the FSOC, he stated that although AI will “create great efficiencies across the economy,” current regulatory guidance is insufficient.15 Gensler further noted that future guidance and regulation will require a cross-agency approach.16 In addition to U.S. regulation, the European Parliament and Council released the Artificial Intelligence Act, which will create a comprehensive AI framework in the European Union.17The result will surely be a flurry of additional regulations, rulemaking and hearings over the coming year as regulators and lawmakers look to exercise leadership and influence in this developing arena. Industry participants will have to carefully monitor developments and regulations in their respective regulatory areas as they are announced and consider how to adopt best practices to ensure they maintain compliance with federal laws and guidance.Footnotes1. Exec. Order No. 14110, 88 Fed. Reg. 75191 (Oct. 30, 2023) (hereinafter “Order”)2. See generally WHITE HOUSE OFF. OF SCI. AND TECH. POL’Y, BLUEPRINT FOR AN AI BILL OF RIGHTS (2022); Artificial Intelligence Risk Management Framework (AI RMF 1.0) (https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.100-1.pdf)3. The Council will be chaired by the White House Deputy Chief of Staff for Policy and include representatives from each agency.4. “The term “dual-use foundation model” means an AI model that “is trained on broad data; generally uses self-supervision; contains at least tens of billions of parameters; is applicable across a wide range of contexts; and that exhibits, or could be easily modified to exhibit, high levels of performance at tasks that pose a serious risk to security, national economic security, national public health or safety, or any combination of those matters.” See Order, supra note 1.5. Id.6. Id.7. FACT SHEET: President Biden Issues Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence, White House, https://www.wh

impacts will be felt on an even wider range of agencies, programs and industries than those listed in its directives. Agencies will be developing guidance, standards and eventually regulations that will help establish best practices for the evolving field of privacy and cybersecurity in AI. Much like the NIST Cybersecurity Framework, these new standards and guidance may become important elements of best practices for AI governance, privacy and security. Stakeholders should keep abreast of these developments and any collaborative processes that follow to take the opportunity to be heard, particularly when there is potential impact to businesses. “[P]rivacy enhancing technologies” in the EO refer to “any software or hardware solution, technical process, technique, or other technological means of mitigating privacy risks arising from data processing, including by enhancing predictability, manageability, disassociability, storage, security, and confidentiality.” Section 3(z). Exec. Order No. 14110, 88 FR 75191 (2023), Section 9(a).Id.Id. at Section 9(b); the term “differential-privacy guarantee” is defined by the EO as “protections that allow information about a group to be shared while provably limiting the improper access, use, or disclosure of personal information about particular entities.” Section 3(j).Id. at Section 9(c)(i).Id. at Section 4.1(a)(i)(C). A “dual-use foundation model” is defined by the EO to mean “an AI model that is trained on broad data; generally uses self-supervision; contains at least tens of billions of parameters; is applicable across a wide range of contexts; and that exhibits, or could be easily modified to exhibit, high levels of performance at tasks that pose a serious risk to security, national economic security, national public health or safety, or any combination of those matters, such as by:. . . (ii) enabling powerful offensive cyber operations through automated vulnerability discovery and exploitation against a wide range of potential targets of cyber attacks;

light of the President’s AI Executive Order and the antitrust agencies’ expansive antitrust enforcement posture, we can expect that the agencies will be closely scrutinizing the development and use of advanced AI technology and related inputs (such as data, computational resources, cloud computing services, and chips). Moreover, businesses in this space should be careful to avoid interactions that could be perceived as potentially unlawful collaborations and guard against the exchange of competitively sensitive information. Hogan Lovells attorneys will be closely monitoring the federal antitrust regulators’ activities in furtherance of this Executive Order and are well-positioned to provide guidance to help clients navigate this rapidly developing antitrust enforcement landscape.References1 United States, Executive Office of the President [Joe Biden]. Executive order 14110: Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. 30 October 2023. Federal Register, 88 FR 75191 at § 2(a)-(h) (available here).2 Id. at §5.3(a).3Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, §5.3(a).4See, e.g., Algorithms and Collusion – Note by the United States, available at https://www.justice.gov/atr/case-document/file/979231/download; Principal Deputy Assistant Attorney General Doha Mekki of the Antitrust Division Delivers Remarks at GCR Live: Law Leaders Global 2023 (discussing focus on information-exchange theories), available at https://www.justice.gov/opa/speech/principal-deputy-assistant-attorney-general-doha-mekki-antitrust-division-delivers-0; FTC, Generative AI Raises Competition Concerns (June 29, 2023 blog post) (“[I]f generative AI itself becomes an increasingly critical tool, then those who control its essential inputs could wield outsized influence over a significant swath of economic activity.”), available at https://www.ftc.gov/policy/advocacy-research/tech-at-ftc/2023/06/generative-ai-raises-competition-

President Joseph Biden issued an executive order on October 30 designed to protect against the risks of artificial intelligence (AI) while encouraging the global growth and expansion of AI development and use.Although the executive order (EO), titled Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, EO 14110, 88 Fed. Reg. 75191-75226 (Nov. 1, 2023), is largely not self-effectuating and thus does not have a practical impact at this time, it provides a robust roadmap of the Biden administration’s anticipated policy, regulatory, legal, and practical changes that will affect a broad range of industries—not only those that develop AI, but also those that use AI. Of particular import is the focus on technology and healthcare, privacy, immigration, and accessibility—all areas of significant ongoing attention from the Biden administration.The EO requires, at least, the following:Developers of powerful AI systems must disclose their safety test results and other information to the US government.NIST must publish requirements for testing prior to public release (“red teaming”) and various implementation functions are assigned to other federal agencies, including the Department of Homeland Security (DHS) and the Department of Energy. The DHS will also establish an AI Safety and Security Board. This is akin to what is likely already occurri