News & Analysis as of

Section 112

Baker Donelson

Presidential Exemptions Offer Temporary Relief for Sterilization Facilities Amid Legal Challenges

Baker Donelson on

In recent years, ethylene oxide (EtO) has emerged as a focal point in environmental and regulatory discussions due to its dual role as a critical sterilizing agent and a human carcinogen. Widely used in commercial...more

BakerHostetler

Federal Circuit Confirms that Enablement of an Anticipatory Prior Art Reference Is Distinct from Enablement Under Section 112

BakerHostetler on

In Agilent Techs., Inc. v. Synthego Corp., the Federal Circuit addressed the difference between the enablement standard for an anticipatory prior art reference (under 35 U.S.C. § 102) and that for an applicant/patentee’s own...more

McDermott Will & Schulte

Specification controls: Written description must be clear

The US Court of Appeals for the Federal Circuit reversed a district court’s decision upholding patent validity, finding that the subject patent’s specification clearly established that the written description failed to...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re BAC IP B.V. (Fed. Cir. 2025)

A patent applicant dissatisfied by an patent examiner's rejection of that applicant's claims in ex parte prosecution has recourse by appeal to the Patent Trial and Appeal Board (PTAB) under 35 U.S.C. § 134, and to the Federal...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Clarifies that Enablement of Prior Art is a Separate (and Distinct) Inquiry from Enablement of Claims in a Patent

In an appeal from an inter partes review, the Federal Circuit recently clarified that the enablement inquiry applied to prior art references in the context of an anticipation defense differs from the enablement inquiry...more

McDermott Will & Schulte

CRISPR Clarity: Enablement Is Analyzed Differently Under §§ 102 and 112

In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Mitek Systems Inc. v. United Services Automobile Association

Mitek Systems Inc. v. United Services Automobile Association, Appeal No. 2023-1687 (Fed. Cir. June 12, 2025) In our Case of the Week, the Federal Circuit examined the limits of declaratory judgment jurisdiction for a...more

Wolf, Greenfield & Sacks, P.C.

Practical Guide to Claiming Small Molecules with Functional Language

Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more

Ervin Cohen & Jessup LLP

Patents Must Describe the “How” - A Reminder That Functional Claims Need Structural Support

On April 30, 2025, the Federal Circuit issued a decision in Fintiv, Inc. v. PayPal Holdings, Inc. (No. 23-2312), issued on April 30, 2025, upholding the invalidation of Finitiv Inc.’s (“Finitiv”) mobile wallet patents related...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Reaffirms “Carried Forward” Requirement for Provisional Priority in Reexams and Reissues

Requesters should make sure to double cite to non-provisional and provisional if they require a provisional filing date for prior art....more

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Sheppard Mullin Richter & Hampton LLP

2024 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are excited to present the second edition of Sheppard Mullin’s “Year in Review” report, which provides a comprehensive summary of the key precedential Federal Circuit decisions related to patent law in 2024. Building on...more

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

Polsinelli on

Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

Volpe Koenig

Artificial Ingenuity: Is Generative AI the New 'Person of Ordinary Skill' in Patent Law?

Volpe Koenig on

The concept of the "person of ordinary skill in the art" (POSITA) remains pivotal in patent law, particularly in evaluating obviousness under 35 U.S.C. § 103 and compliance with enablement and written description requirements...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Written Description and Enablement Depend on What a Patent 'Claims,' Not What the Claims Cover

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Baker Botts L.L.P.

35 U.S.C. § 112 in IPR: I know you cannot use it to invalidate a claim, but how about breaking the priority chain?

Baker Botts L.L.P. on

It is well established that “a petitioner in an inter partes review … is not permitted to assert a ground of unpatentability under 35 U.S.C. § 112.” Dexcowin Golabl, Inc. v. Aribex, Inc., IPR2016-00436, Paper 12 (PTAB July 7,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2024 #3

Vascular Solutions LLC v. Medtronic, Inc., Appeal No. 24-1398 (Fed. Cir. Sept. 16, 2024) In our Case of the Week, the Federal Circuit evaluated certain heavily litigated claims directed to guide catheters. The patents...more

Goldberg Segalla

Big Wheel Keep on Turnin’, EPA Keep on Churnin’ Out Regulations

Goldberg Segalla on

Stationary combustion turbines, often referred to as gas turbines, are used to generate high volumes of electricity at power stations, dams, and industrial centers. Despite their size, noise, and prodigious output, these...more

Jones Day

Petition Denied for Lacking Section 112(f) Construction and Fintiv

Jones Day on

On March 7, 2024, the PTAB denied institution in 10x Genomics, Inc. v. President and Fellows of Harvard College, IPR2023-01299, Paper 15 (PTAB Mar. 7, 2024) (“Decision”). The PTAB denied institution on two separate grounds:...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

McDermott Will & Schulte

PTO Continues to Wave Wands in Assessing Enablement

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Mitchell, Williams, Selig, Gates & Woodyard,...

112(r)/Air Enforcement: U.S. Environmental Protection Agency and Downington Town, Pennsylvania, Water Authority Enter into...

The United States Environmental Protection Agency (“EPA”) and Downington Regional Water Authority (“DRWA”) entered into an Expedited Settlement Agreement (“ESA”) addressing alleged violations of Section 112(r) of the Clean...more

Bradley Arant Boult Cummings LLP

More Antibody Claims Falling Under Post-Amgen Scrutiny

With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more

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