Tag: guidance

New USPTO Obviousness Guidelines Seek to Refine Examiner Evaluations Likely Making Path to Patent Grant More Difficult and Potentially Opening Door to More Patent Challenges

On February 27, the United States Patent and Trademark Office (USPTO) released new guidance aimed at enhancing the methodology used to assess the obviousness of patent applications. The updated USPTO guidance emphasizes the need for a clear articulation of a reasoned analysis, grounded in relevant facts, in determining whether a claimed invention meets the criteria of being obvious. The USPTO asserts that this initiative is in line with the directives of the U.S. Supreme Court’s landmark decision in KSR Int’l Co. v. Teleflex Inc., advocating for a flexible approach toward obviousness evaluations.

The USPTO suggests that this newly issued guidance will act as a practical manual for USPTO examiners, applicable to all utility patent applications under review or contestation. It allegedly aims to ensure a standardized application of the law of obviousness across various cases.

A brief synopsis provided from the USPTO’s updated guidance and garnered since the KSR decision of the Federal Circuit include:

  • In KSR, the Supreme Court instructed the Federal Circuit that persons having ordinary skill in the art also may glean suggestions from the prior art that go beyond the primary purpose for which that prior art was produced. “Thus, the Supreme Court taught that a proper understanding of the prior art extends to all that the art reasonably suggests and is not limited to its articulated teachings regarding how to solve the particular technological problem with which the art was primarily concerned.”
  • Since KSR, the Federal Circuit has confirmed that “the flexible approach to obviousness encompasses not only how to understand the scope of prior art, but also how to provide a reasoned explanation to support a conclusion that claims would have been obvious.”
  • However, a flexible approach to obviousness does not negate the need for articulated reasoning and evidentiary support, the USPTO said.
  • Obviousness decision-makers must examine all the evidence before them.
  • The USPTO states that, “there is no one-size-fits-all approach to crafting an obviousness rejection.”

Kathi Vidal, Director of the USPTO, expressed the agency’s commitment to issuing reliable patent rights while ensuring clarity and consistency across the board. “Our initiative aims at bolstering transparency and uniformity within our processes and across the innovation landscape,” Vidal remarked.

The implications of this USPTO guidance extend to design patents as well, with the USPTO keenly awaiting the Federal Circuit’s verdict in LKQ Corp. v. GM Global Technology Operations LLC.

Additionally, the USPTO makes notes that it is gearing up to explore the influence of artificial intelligence on the landscape of prior art and the competence of someone skilled in the art, particularly how these factors interplay with patentability assessments including obviousness determinations. The USPTO plans to invite public commentary on these topics soon.

The updated USPTO guidelines initially appear to increase the burden on the patent applicant or the patentee to show that a claimed invention is not obvious by allowing the obviousness decision-makers (e.g., USPTO examiners and judges of the Patent Trial and Appellate Board (PTAB)) more flexibility in rejecting claims and to go outside of the boundaries of patent documents used to reject claims as long as reasoning is articulated and evidentiary support is provided. To counter an obviousness rejection made by an obviousness decision-maker, patent applicants or patentees should review obviousness rejections for a clearly articulated obviousness reasoning, including evidentiary support (e.g., not purely the examiner or judge’s argument) that is sound (e.g., actually supports the examiners or judges’ positions). Patent applicants and patentees also may need to rely on more expert declarations or affidavits to help overcome obviousness rejections.

Copyright © 2024 Womble Bond Dickinson (US) LLP All Rights Reserved.
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Agriculture Groups Sue FDA on Chlorpyrifos Ban

  • As previously reported, the Environmental Protection Agency (EPA) published a final rule on August 30, 2021 that revoked all tolerances for the pesticide chemical chlorpyrifos on raw agricultural commodities; the rulemaking was driven by toxicity concerns, primarily concerning exposure in children. The tolerances are set to expire on February 28, 2022, effectively banning the use of chlorpyrifos on food crops. In light of the expiration, FDA published a guidance document to assist food producers and processors that handle foods which may contain chlorpyrifos restudies.
  • In October of 2021, agriculture stakeholders submitted formal written objections and a request to stay the tolerance revocations to EPA. More than 80 stakeholders signed the document, arguing that significant harms would result from banning chlorpyrifos and urging the agency to stay implementation of the rule until objections were formally addressed by EPA.
  • Agriculture stakeholder groups are now seeking a court injunction against EPA’s ban on chlorpyrifos. On February 10, 2022, agricultural trade groups representing thousands of members filed a lawsuit against EPA before the Eight Circuit Court of Appeals, alleging that the agency ignored its own scientific findings regarding 11 high-benefit and low-risk crop uses for chlorpyrifos and that the revocation will cause irreparable damage. It remains to be seen how EPA will respond to the lawsuit.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

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© 2022 Keller and Heckman LLP

USCIS Issues New Policy Guidance for O-1B Visas

United States Citizenship and Immigration Services (“USCIS”) recently issued policy guidance to clarify how to determine the appropriate visa classification for persons of extraordinary ability in the arts. Given the massive changes in the entertainment industry in the past year, including the increasing popularity of internet and streaming services, this guidance provides essential insight for those seeking to understand the nuances of O-1B nonimmigrant visas and determine which visa applies to their unique circumstances.

O-1 Visa Program for Individuals with Extraordinary Ability or Achievement

The O-1 nonimmigrant visa program provides nonimmigrant visas for individuals who possess extraordinary ability in the sciences, arts, education, business, or athletics, or who have demonstrated extraordinary achievement in the motion picture or television industry and been recognized nationally or internationally for those achievements.

The O-1 nonimmigrant visa program is broken down into the following classifications:

  • O-1A: Individuals with an extraordinary ability in the sciences, education, business, or athletics (not including the arts, motion pictures or television industry);
  • O-1B (Arts): Individuals with an extraordinary ability in the arts;
  • O-1B (MPTV): Individuals with extraordinary achievement in the motion picture or television industry.

Generally, to qualify for an O-1 visa, a beneficiary must demonstrate “sustained national or international acclaim” in their respective field. To prove this, applicants must provide evidence of their credentials, including national or international awards or prizes, membership in professional organizations in their respective field, published articles in notable trade publications, high salary for their services, as well as other relevant evidence of exceptional expertise.

Under the O-1B category, as noted above, individuals in the entertainment industry can demonstrate either extraordinary ability in the arts or extraordinary achievement in the motion picture and television industry. With the recent shifts in the entertainment industry, including the prevalence of household names from YouTube, TikTok, Instagram, etc., it has become increasingly common for applicants to possess qualities that fall under both the O-1B (Arts) and the O-1B (MPTV) categories.

Determining the Relevant Standard for Artists with Some Connection to MPTV

The USCIS Policy Manual acknowledges the difficulties associated with petitions that have elements of both O-1B (Arts) and O-1B (MPTV) classifications. According to the newly issued guidance, inclusion in the motion picture or television industry is not limited to whether artistic content will air on television or movie screens, noting that “USCIS considers streaming movies, web series, commercials, and other programs with formats that correspond to more traditional motion picture and television productions to generally fall within the MPTV industry’s purview.” Indeed, USCIS gives weight to whether an individual”s work aligns with industry organizations such as the Academy of Television Arts and Sciences.

However, under USCIS guidance, not all television stars are considered equal for the purpose of visa qualification. For instance, reality television poses an interesting problem because many of the “stars” are non-actors involved in a competition of some sort that takes place on television. According to USCIS, contestants on reality television programs fall outside of the MPTV industry, but judges, hosts, and those employed by the production company generally fall within industry parameters.

Video blogging, a staple of the increasingly popular YouTube and TikTok platforms, poses similar questions. However, USCIS makes clear that static web content, like video blogs, generally falls outside the O-1B (MPTV) classification and is more appropriate for O-1B (Arts) petitions. USCIS notes that if an artist’s work or appearance on an MPTV production is incidental to their non-MPTV work as an artist, the MPTV classification may not be appropriate.

Guidance for O-1B Visas

The newly-issued guidance provides some clarification of the nuances that distinguish O-1B (Arts) beneficiaries from O-1B (MPTV) beneficiaries. Potential beneficiaries and practitioners can continue to consult the USCIS Policy Manual for up-to-date guidance in this quickly changing industry.

Article By Raymond G. Lahoud of Norris McLaughlin P.A.

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©2022 Norris McLaughlin P.A., All Rights Reserved

IRS Tax Treatment of Wellness Program Benefits

Business people doing yoga on floor in office

The IRS Office of Chief Counsel recently released a memorandum providing guidance on the proper tax treatment of workplace wellness programs. Workplace wellness programs cover a range of plans and strategies adopted by employers to counter rising healthcare costs by promoting healthier lifestyles and providing employees with preventive care. These programs take many forms and can encompass everything from providing certain medical care regardless of enrollment in health coverage, to free gym passes for employees, to incentivized participation- based weight loss programs. Due to the wide variation in such plans the proper tax treatment can be complicated. However, the following points from the IRS memo can help business owners operating or considering a wellness program evaluate their tax treatment.

First, the memo confirmed that coverage in employer-provided wellness programs that provide medical care is generally not included in an employee’s gross income under section 106(a), which specifically excludes employer-provided coverage under an accident or health plan from employee gross income. 26 USC § 213(d)(1)(A) defines medical care as amounts paid for “the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body,” transportation for such care, qualified long term care services, and insurance (including amounts paid as premiums).

Second, it was made clear that any section 213(d) medical care provided by the program is excluded from the employee’s gross income under section 105(b), which permits an employee to exclude amounts received through employer-provided accident or health insurance if it is paid to reimburse expenses incurred by the employee for medical care for personal injuries and sickness. The memo emphasized that 105(b) only applies to money paid specifically to reimburse the employee for expenses incurred by him for the prescribed medical care. This means that the exclusion in 105(b) does not apply to money that the employee would receive through a wellness program irrespective of any expenses he incurred for medical care. 26 CFR 1.105-2.

Third, any rewards, incentives or other benefits provided by the wellness program that are not medical care as defined by section 213(d) must be included in an employee’s gross income. This means that cash prizes given to employees as incentives to participate in a wellness program are part of the employee’s gross income and may not be excluded by the employer. However, non-money awards or incentives might be excludable if they qualify as de minimis fringe benefits (ones that are so small and infrequent that accounting for them is unreasonable or impracticable). 26 USC § 132(a)(4). The memo gives the example of a t-shirt provided as part of a wellness program as such an excludable fringe benefit, and notes that money is never a de minimis fringe benefit.

Fourth, payment of gym memberships or reimbursement of gym fees is a cash benefit, even when received through the wellness program, and must be included in gross income. This is because cash rewards paid as part of the wellness program do not qualify as reimbursements of medical care and cannot be a fringe benefit.

Fifth, where an employee chooses a salary reduction to pay premiums for healthcare coverage and the employer reimburses the employee for some or all of the premium amount under a wellness program, the reimbursement is gross income.

These points laid out in the IRS memo provide a solid foundation for understanding the tax treatment of workplace wellness programs and should be kept in mind by business owners deciding how to structure new wellness plans for their employees, or ensuring the tax compliance of existing plans.

SEC (Securities and Exchange Commission) Guidance on the Testimonial Rule and Social Media

Godfrey Kahn

In March 2014, through question and answer format, the Division of Investment Management issued an Investment Management Guidance Update on an adviser’s or investment advisory representative’s (IAR) ability to use social media and to promote client reviews of their services that appear on independent, third-party social media sites.

Section 206(4) of the Advisers Act and Rule 206(4)-1(a)(1) (the testimonial rule) prohibit investment advisers or IARs from publishing, circulating, or distributing any advertisement that refers to any testimonial concerning the investment adviser or any advice, analysis, report, or other service rendered by such investment adviser. While the rule does not define “testimonial,” the staff previously has interpreted it to mean a “statement of a client’s experience with, or endorsement of, an investment adviser.”

Third Party Commentary. The guidance clarifies that in certain circumstances, an investment adviser or IAR may publish public commentary from an independent social media site if (i) the social media site’s content is independent of the investment adviser or IAR, (ii) there is no material connection between the social media site and the investment adviser or IAR that would call the site’s or the commentary’s independence into question, and (iii) the investment adviser or IAR publishes all of the unedited comments appearing on the independent social media site. The staff explained that publishing commentary that met these three criteria would not implicate the concerns of the testimonial rule and, therefore, an investment adviser or IAR could include such commentary in an advertisement.

Inclusion of Investment Adviser Advertisements on Independent Sites. The guidance also addresses the existence of an investment adviser’s or IAR’s advertisement on an independent site and notes that such presence would not result in a prohibited testimonial provided that (i) it is readily apparent to the reader that the advertisement is separate from the public commentary and (ii) advertising revenue does not influence, in any way, the determination of which public commentary is included or excluded from the independent site.

Reference by Investment Adviser to Independent Social Media Site Commentary in a Non-Social Media Advertisement (e.g., radio or newspaper). In the guidance, the staff explained that investment advisers or IARs could reference, in a non-social media advertisement, an independent social media site. For example, an adviser could state in its newspaper ad “see us on Facebook or LinkedIn” to signal to clients and prospective clients that they can research public commentary about the investment adviser on an independent social media site. In contrast, however, the investment adviser or IAR may not publish any testimonials from an independent social media site in a newspaper, for example, without implicating the testimonial rule.

Client Lists. The guidance also addressed posting of “contacts” or “friends” on the investment adviser’s or IAR’s social media site. Such use is not prohibited, provided that those contacts or friends are not grouped or listed in a way that identifies them as current or former clients. The staff carefully noted, however, any attempts by an investment adviser or IAR to imply that those contacts or friends have received favorable results from the advisory services would implicate the testimonial rule.

Fan/Community Pages. The guidance stated that a third-party site operating as a fan or community page where the public may comment ordinarily would not implicate the testimonial rule. However, the guidance cautioned investment advisers or IARs to consider the material connection and independence rules discussed above prior to driving user traffic to such a site, including through the publication of a hyperlink.

Sources: Investment Management Guidance Update, No. 2014-4, Guidance on the Testimonial Rule and Social Media (March 2014); Investment Company Institute Memorandum Regarding the Advisers Act Testimonial Rule and Social Media Guidance (April 1, 2014).

Article By:

Christopher M. Cahlamer
Elizabeth J. Chandler
Laura A. Hawkins
Susan Hoaglund
Helge Lee
Of:
Godfrey & Kahn S.C.