Posts Tagged: "Method Claims"

This article examines Supreme Court and Federal Circuit analyses of patent eligibility under 35 U.S.C. § 101 where the patent claims at issue were directed to Life Sciences-related technologies. I first examine this topic in the context of composition of matter patent claims and then in the context of method claims. As reflected in the below discussion, while the § 101 case law is fairly straightforward with respect to composition claims, the case law is murkier when it comes to method claims.

Buried in the claim language, conditional limitations may be a vulnerability in an otherwise valuable claim. A conditional limitation is a claim feature that depends on a certain condition being present. For example, when or if condition X is present, feature Y is implemented or has effect. Without condition X, feature Y may be dormant or have no effect. Patent owners should be cognizant of possible conditional limitations implications because conditional limitations may affect claim validity and infringement as discussed below in the context of recent U.S. Patent Office and Federal Circuit cases. In Ex Parte Schulhauser, the Patent Trial and Appeal Board (“the Board”) held certain claims as unpatentable based on conditional limitations.

The ‘156 patent discloses methods of treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin, e.g., renal disease, metabolic acidosis, congestive heart failure. Defendants alleged that the asserted claims are patent ineligible because the claims recite a natural law. Plaintiffs argued claims of the ’156 patent are directed towards methods of treating the targeted patient population with metabolic diseases using non-naturally existing DPP-IV inhibitors, which alter the natural state of the body in a new and useful way, and hence do not fall within the natural phenomena exception… Superficially, this decision may appear to be consistent with Mayo – methods of treatment claims that manipulate natural biological processes are considered to be directed to patent ineligible subject matter under § 101. However… it is not perfectly clear that the treatment claims of the patent-at-issue are directed to a law of nature or an abstract idea. Claim 1 is directed to an active practical application of a compound for treatment… The decision also appears at odds with the USPTO Subject Matter Eligibility Examples.

Method or process claims are relatively easy to write once you know what the core invention is and what is necessary to be included in the claim in order to overcome the prior art. Method or process claims will include active steps to achieve a certain result. In method claims the transition is typically either “comprising” or “comprising the steps of.” While legally there may be some distinction between these two different transitions, both are acceptable. It is also important to understand that each of the steps in a method or process claims use gerunds, which are a form of a verb that ends in “ing” and operates to direct the action that is to take place.

As the amici correctly argue, the panel’s decision striking down Sequenom’s noninvasive prenatal test strikes at the very heart of the patent system. Revolutionary diagnostic testing methods that cost tens of millions of dollars to produce should be the flagship of the modern patent system. But the panel’s misapplication of Mayo calls into doubt many meritorious inventions that benefit us all. Moreover, the panel’s reasoning simply cannot be squared with several innovations that the Supreme Court has historically upheld as proper statutory subject matter. Hopefully the entire Federal Circuit will agree to take up this important case so that vital innovations such as Sequenom’s patented method continue to be produced.

The en banc Court reversed the previous panel, and expanded the circumstances under which an alleged infringer may be liable under §271(a). In addition to circumstances identified by the panel, liability may arise if “an alleged infringer conditions participation in an activity or the receipt of a benefit upon performance of a step or steps of the patented method, and establishes the manner or timing of that performance.” When that standard is satisfied, the actions of a third party may be attributed to the alleged infringer, who thereby directly infringes under §271(a), even though there was no “mastermind” acting though a formal agent.