Tag Archives: Enablement

Federal Circuit Affirms Patent Rejection for Lack of Enablement in In re Pen

by Dennis Crouch

The Federal Circuit (CAFC) recently affirmed a USPTO enablement rejection -- holding that the patentee did not enable the "full scope" of the claimed invention.  In re Pen, 23-2282 (Fed. Cir. 2024) (non-precedential).  As an aside, the listed inventor's legal name is "The Pen;" first and last name respectively, with no middle initial.  Based upon Pen's address, he is related to "The People's Email Network."  In the case, Pen represented himself pro se.


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Discerning Signal from Noise: Navigating the Flood of AI-Generated Prior Art

by Dennis Crouch

This article explores the impact of Generative AI on prior art and potential revisions to patent examination standards to address the rising tidal wave of AI-generated, often speculative, disclosures that could undermine the patent system's integrity.


The core task of patent examination is identifying quality prior art.  References must be sufficiently accessible, clear, and enabling to serve as legitimate evidence of what was previously known.  Although documents are widely available today via our vast network of digital communications, there is also increasing junk in the system -- documents making unsubstantiated claims that are effectively science fiction.  Patent offices prefer patent documents as prior art because they are drafted to meet the strict enablement standards and filed with sworn veracity statements. Issued patents take this a step further with their imprimatur of issuance via successful examination.  Many of us learned a mantra that "a prior art reference is only good for what it discloses" -- but in our expanding world of deep fakes, intentional and otherwise, is face value still worth much?

In a new request for comments (RFC), the USPTO has asked the public to weigh in on these issues -- particularly focusing on the impact of generative artificial intelligence (GenAI) on prior art.


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Without Undue Experimentation vs Without Any Experiments

by Dennis Crouch

I was rereading the Supreme Court's recent enablement decision of Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) and was struck by the Supreme Court's statement that its 19th Century decision of Wood v. Underhill, 46 U.S. 1 (1847) "establish[ed] that a specification may call for a reasonable amount of experimentation to make and use a patented invention."  This statement from Amgen is surprising because Chief Justice Taney's decision in Wood includes a seemingly contrary statement that bars any experimentation


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What is Next for Enablement and Written Description of Antibody Claims?

by Dennis Crouch

I had been following the case of Teva v. Lilly for a few years.  Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. U.S. Patent Nos. 8,586,045, 9,884,907 and 9,884,908.  The patents cover Teva's drug Ajovy, and allegedly cover Lilly's Emgality. Both drugs were approved by the FDA in September 2018.  A Massachusetts jury sided with Teva and awarded $177 million in damages, including a controversial future-lost-profit award.

Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva's patent claims were invalid as a matter of law for lacking


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