MVS Filewrapper® Blog: USPTO Issues New Examination Guidelines for Patent Subject Matter Eligibility

The basic requirements for filing a U.S. utility patent are rather straightforward. Patents are granted for new, useful and non-obvious processes, products or compositions of matter. Similarly, any new, useful and non-obvious improvement to these categories of inventions may be granted a patent. Although seemingly straightforward, the three basic requirements for patentability are impacted by an evolving legal landscape which is largely dictated by court-created case law. 

 

For much of the last thirty years, the case law addressing patent eligibility has had some consistency.  However, a series of court decisions in recent years has changed the understanding of what is considered patent-eligible.  As a result, the USPTO released guidelines last month providing an analytical framework to evaluate whether a patent claim meets these patent subject matter eligibility requirements (as set forth in 35 USC § 101). These guidelines titled "Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products" are particularly relevant for those dealing with patent applications (and portfolios) in the fields of biotechnology, chemistry and/or life sciences. Although subject matter eligibility is applicable for all fields of patenting, the guidelines were provided to patent examiners to specifically address examination of claims “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products” (i.e. applying the legal principles set forth in the Myriad and Prometheus decisions, see earlier FileWrapper postings for further detail).

 

A few key points to consider in light of the USPTO guidelines (available at http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf) include the following:

 

1.      The guidelines apply to all claims (excluding "abstract ideas")

Any claims that “recite or involve laws of nature/natural principles, natural phenomena, and/or natural products” are to be examined using the new guidelines. The only exclusion is a claim which is alleged to recite an “abstract idea,” which will not be examined using the new guidelines.

 

2.      Natural products are very broadly defined

The guidelines define natural products broadly, including “substances found in or derived from nature.” The take-home for patent Examiners is that claimed subject matter for a product must be non-naturally occurring to be subject matter eligible. In addition, to meet requirements of non-obviousness, the non-naturally occurring product must be “markedly different in structure from naturally occurring products.”

 

3.      There is a 3-part eligibility test to be applied by Examiners

The guidelines provide Examiners with a decision tree for determining patent subject matter eligibility (reproduced at the beginning of this post).  The first question asked by an examiner when evaluating a patent claim will be whether the claimed invention is directed to a statutory patent-eligible subject matter category (process, machine, manufacture, or composition of matter).

If the first threshold is met, the examiner will next question whether the claim recites or involves a judicial exception, which therefore precludes patentability. Examples of these exceptions include abstract ideas, laws of nature (i.e. natural principles), natural phenomena, and natural products.

Finally, the third question to be assessed by an examiner under the guidelines is whether the claim as a whole recites something "significantly different" than the mentioned judicial exception. The guidelines provide more extensive analysis of what constitutes a "significant" difference. Generally, there must be a showing that the product claimed has a marked difference from what exists in nature, or also recites a meaningful limitation to add something of significance to the patent claim.



We note that the guidelines were created by the USPTO for the USPTO examiners. Therefore, they are an interpretation of case law relating to subject matter eligibility. They are not binding law, and they are subject to change and/or judicial challenge. However, they can be helpful in navigating the area between patentable and unpatentable subject matter. 

 

MVS Filewrapper® Blog: Who May Bring a Federal False Advertising Suit?

     The Supreme Court's recent decision in Lexmark International, Inc. v. Static Control Components, Inc. prescribed the appropriate framework for determining whether a plaintiff has standing in a false advertising action under the 15 U.S.C. 1125(a).  Prior to this decision, there were three competing approaches to determining whether a plaintiff has standing to bring suit under the Lanham Act: 

 

·         The Third, Fifth, Eighth and Eleventh Circuits utilized an antitrust standing or a set of factors laid out in Associated General Contractors;

 

·         The Seventh, Ninth and Tenth Circuits used a categorical test which only permits actual competitors to bring false advertising suits under the Lanham Act; and lastly

 

·         The Second Circuit applied a "reasonable interest' approach," under which a Lanham Act plaintiff "has standing if the claimant can demonstrate '(1) a reasonable interest to be protected against the alleged false advertising and (2) a reasonable basis for believing that the interest is likely to be damaged by the alleged false advertising.'"

 

     In this case, the Sixth Circuit applied the Second Circuit's reasonable-interest test and concluded that Static Control had "standing because it 'alleged a cognizable interest in its business reputation and sales to remanufacturers and sufficiently alleged that th[o]se interests were harmed by Lexmark's statements to the remanufacturers that Static Control was engaging in illegal conduct."  The Supreme Court held that in order to have standing, a plaintiff "ordinarily must show that its economic or reputational injury flows directly from the deception wrought by the defendant's advertising; and that occurs when deception of consumers causes them to withhold trade from the plaintiff." Thus, direct application of a zone-of-interest test and proximate-cause requirement "supplies the relevant limits on who may sue under §1125(a)" and supplants the tests previously applied by the lower courts.   

MVS Filewrapper® Blog: StoneEagle v. Gillman – Patent Inventorship, Authorship, and Ownership

In StoneEagle Services, Inc.,v. Gillman the Federal Circuit confirmed that assistance in reducing an invention to practice generally does not contribute to inventorship. In this case, the issue centered on whether there was a sufficient controversy regarding inventorship for the case to remain in federal court.  The plaintiff alleged that the defendant had "falsely claimed that it is his patent, that he wrote the patent, that it is on his computer, and that he ‘authored’ or ‘wrote’ it, or words to that effect.” 

 

The court determined that the most favorable possible inference in favor of the plaintiff only indicated that the defendant assisted in constructively reducing an invention to practice by drafting the patent application.  The court confirmed that those activities confer no more rights of inventorship than activities in furtherance of an actual reduction to practice, which is usually insufficient to rise to the level of inventorship.  As the court concluded, if they were to hold otherwise, "patent attorneys and patent agents would be co-inventors on nearly every patent. Of course, this proposition cannot be correct."

 

The full decision is available here.

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