Patent Counseling & Strategies

By Frank Amini, Ph.D. and Lekha Gopalakrishnan, Ph.D.

Under the U.S. Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”[1]  Common exceptions to what can be patented include laws of nature, natural phenomena, and abstract ideas[2].

In recent years, the U.S. Supreme Court has expanded the scope of the common exceptions to what can be patented.  For instance, in Mayo v. Prometheus (Mayo), the U.S. Supreme Court held that methods of administering a drug to a patient, measuring metabolites of that drug, and deciding whether to increase or decrease the dosage of the drug are not eligible for patenting because the methods pertain to natural phenomena[3].  Likewise, the U.S. Supreme Court later held in Alice Corp. v. CLS Bank International (Alice) that a computer-implemented electronic escrow service for facilitating financial transactions was not eligible for patenting because it pertained to an abstract idea[4].

The lower courts have been relying on Alice and Mayo to invalidate many patents related to diagnostic methods and computer-implemented processes.  As result, the United States Patent and Trademark Office (USPTO) has issued numerous patent examination guidelines and supporting examples for evaluating the patent eligibility of inventions in view of the aforementioned rulings[5].

However, the previously issued USPTO guidelines were found to lack clarity, consistency and predictability in determining patent eligibility.  In fact, the USPTO has admitted that “it has become difficult in some cases for inventors, businesses, and other patent stakeholders to reliably and predictably determine what subject matter is patent eligible.”[6]  The USPTO has also admitted that “concerns have been raised that different examiners within and between technology centers may reach inconsistent results” in their patent eligibility analyses[7].

In an effort to address the aforementioned concerns, the USPTO published its “2019 Revised Patent Subject Matter Eligibility Guidance” on January 7, 2019 (“New Guidelines”)[8].  The New Guidelines modify the prior guidelines by directing the Examiners to perform a more detailed and systematic patent eligibility analysis.

The steps involved in determining the patent eligibility of inventions when one combines the prior guidelines with the New Guidelines are illustrated in Figure 1.  The steps are also described herein as Steps 1-4.
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The Patent Trial and Appeal Board (PTAB) dismissed three inter partes review (IPR) proceedings involving the University of Florida based on sovereign immunity.

As background, the University of Florida Research Foundation filed a suit in state court alleging breach of a licensing agreement.  Medtronic subsequently brought a counterclaim seeking a declaratory judgment of non-infringement on

Outer space exploration has been expanding.  For instance, since 1998, the International Space Station has served as a platform for scientific research and discoveries in space within modules that are operated by the space agencies of the United States, Russia, Europe, Japan, and Canada[1].  Moreover, efforts are underway to build spacecraft that can

In July 2016, the USPTO launched the Cancer Immunotherapy Pilot Program to provide a fast-track review for cancer immunotherapy-related patent applications without the need for applicants to pay a petition fee.  Under this program, patent applications pertaining to cancer immunotherapy are advanced out of turn for examination, resulting in accelerated review.

The program aims to

The prosecution of a patent application before the U.S. Patent and Trademark Office (USPTO) can be a prolonged and costly process. The patent prosecution process can include the issuance of an Office Action by the USPTO and the subsequent filing of an Office Action response by the applicant. While such communications can occur multiple times

“Rather than rest our decision on formalities, our focus is on what makes our on-sale bar jurisprudence coherent: preventing inventors from filing for patents a year or more after the invention has been commercially marketed, whether marketed by the inventor himself or a third party.”  The Medicines Company v. Hospira, Inc., No. 2014-1469, slip

Regardless of the June 23, 2016 vote on Brexit, all owners of European patents, and all applicants seeking patents in Europe, will have both new options, and a new set of important decisions to make.  Most commentators anticipate that the Unitary Patents (UPs) and the Unified Patent Court (UPC) will come into effect and patentees

The treatment of functional features in design patents was discussed in the recent Federal Circuit case for Sport Dimension, Inc. v. The Coleman Company, Inc., Case No. 15-1553 (Fed. Cir. 2016).  The Court rejected the district court’s claim construction, which completely removed functional features.

As noted by the Court, “[a] design patent cannot claim

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”[1] Common exceptions to what can be patented include laws of nature, natural phenomena, and abstract ideas[2].  In Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Sequenom), the

Patent Marking

Under the patent marking statute, 35 U.S.C. § 287(a),  notice can be actual, or  constructive notice. Actual notice occurs when the alleged infringer is directly informed that its product infringes the patent. Constructive notice can be achieved by affixing a product with the word “patent” or abbreviation “pat.” along with the patent number.