Guidance Update

News & Analysis as of

Treasury Announces 2016-2017 Regulatory Agenda for Employee Benefits

The principal regulators of U.S. employee benefits have recently published updates to their guidance plans for the coming months. ..On August 15, 2016, the U.S. Department of the Treasury and the Internal Revenue Service...more

MAS issues revised Guidelines on Outsourcing

Institutions will need to meet deadlines to conduct a self-assessment of existing outsourcing arrangements, rectify identified deficiencies, and put in place measures to mitigate interim risks where a deficiency is...more

ACA Reporting Update – 2016 Draft Forms & Instructions Released

Since our last ACA Reporting Update, the extended deadlines to distribute Forms 1095-B and 1095-C to covered individuals and employees and to file the forms with the IRS have passed. The IRS has stated, however, that late...more

Final Guidance Released on Considering Climate Change in Environmental Reviews

The President's Council on Environmental Quality has issued its finalized guidance on how federal agencies should consider greenhouse gas emissions and the effects of climate change in reviews of federal actions under the...more

Proposed Rule Relates to Investment Advisers' Business Continuity and Transition Plans

The Securities and Exchange Commission (“SEC”) recently proposed Rule 206(4)-41 under the Investment Advisers Act of 1940 (“Advisers Act”), which would require registered investment advisers (“firms” or “Advisors”) to adopt...more

SEC Proposes Rule Requiring Investment Advisers to Adopt Business Continuity and Transition Plans; Division of Investment...

The U.S. Securities and Exchange Commission (SEC) on June 28, 2016, proposed new Rule 206(4)-4 (Proposed Rule) under the Investment Advisers Act of 1940 (Advisers Act). The Proposed Rule would require every SEC-registered...more

SEC Issues Guidance on Business Continuity Planning for Registered Investment Companies

On June 27, the staff of the Securities and Exchange Commission’s (Commission or SEC) Division of Investment Management (IM) issued a Guidance Update on business continuity planning for registered investment companies...more

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

Financial Services Weekly News - June 2016 #5

Regulatory Developments - FSOC Rescinds GE Capital's SIFI Designation - On June 29, the Financial Stability Oversight Council (FSOC) announced that it had voted unanimously to “rescind its determination that...more

USPTO Releases Update on Patent Eligibility Decision in Light of Enfish

On May 19, the USPTO released an update to patent examiners regarding the U.S. Court of Appeals for the Federal Circuit’s (CAFC) recent decision in Enfish, LLC v. Microsoft Corp. and TLI Communications LLC v. A.V. Automotive,...more

New Sex Discrimination Regs Published

Today the U.S. Department of Labor’s Office of Federal Contract Compliance Programs published its final rule to update its Sex Discrimination Guidelines, expressing its intent to bring the outdated 1970 guidance in line with...more

Two Recent Decisions Put Alice "Step One" on Center Stage at The Federal Circuit

On May 12 and May 17, 2016, the Federal Circuit issued decisions in two § 101 cases, EnFish, LLC v. Microsoft Corp. and In re TLI Communications, LLC. Both authored by Judge Hughes, the decisions illustrate the difficult...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

SEC Staff Updates Guidance on Use of Non-GAAP Financial Measures

On Tuesday May 17, 2016, the staff of the SEC’s Division of Corporation Finance issued new C&DIs relating to Regulation G (which governs use of non-GAAP financial measures in public disclosures generally) and Item 10(e) of...more

FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations

This Friday, May 27, 2016, the US Food and Drug Administration (FDA) will publish its revised Nutrition and Supplement Facts and Serving Size regulations. The Serving Size regulation in public inspection view is close to 180...more

SEC Continues to Turn the Screw on Non-GAAP Financial Disclosures With Updates to Compliance & Disclosure Interpretations

Continuing the SEC’s recent focus on companies’ use of non-GAAP financial measures, the staff of the SEC Division of Corporation Finance issued updated guidance on May 17, 2016 that addresses compliance issues under...more

IPR Motions to Amend: Rays of Hope Despite Gloomy Statistics

The America Invents Act permits patent owners to move to amend claims of a patent subject to inter partes review. However, attempts to amend claims have been largely unsuccessful to date, and some of the hurdles patent owners...more

USPTO Memo Updates Examiner Guidance On Subject Matter Eligibility In View Of Enfish

On May 19, 2016, just weeks after its May 2016 memorandum to examiners providing guidance on subject matter eligibility under § 101, the USPTO issued a new memo updating its guidance to examiners in view of the Federal...more

Small Developments Affordable Housing News

Welcome news for developers of small sites. Following the government’s successful appeal last week against the decision in the West Berkshire Council and Reading Borough Council case nearly a year ago, the National...more

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a...more

Sponsoring events during the upcoming Democratic and Republican national conventions

Recently the House and Senate Ethics Committees issued updated guidance for Members of Congress, Congressional staff, and outside groups to follow in conjunction with events being sponsored during the Republican National...more

"SEC Staff Issues Updated Non-GAAP Financial Measures Guidance"

On May 17, 2016, the staff of the U.S. Securities and Exchange Commission’s (SEC) Division of Corporation Finance issued new and revised compliance and disclosure interpretations (CDIs) regarding the SEC’s rules and...more

FDA Releases (an Updated) Guidance on Medical Foods: What They Are, And What They Are Not

The Food and Drug Administration recently released its Second Edition of its “Guidance for Industry: Frequently Asked Questions About Medical Foods.” The newer version updates previous guidance and provides responses to...more

Federal Circuit Holds District Court Abstractness Analysis Too Abstract for Alice under 35 USC § 101

Clients in the software space now have stronger arguments for subject matter eligibility, following the Federal Circuit decision in Enfish LLC v. Microsoft Corp. (May 12, 2016). The decision also touches on novelty,...more

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although...more

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