Today, March 4, 2014, the U.S. Patent and Trademark Office (USPTO) issued its 2014 Procedure for Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/or Natural Products (hereafter:  the “Guidance”) and provided patent practitioners with helpful and long-awaited guidance on how to formulate a claim involving a law of nature, a natural phenomenon or a natural product so as to be fairly confident that such claim covers patent-eligible subject matter.  For a copy of today's Guidance, click here.  For a copy of the accompanying Eligibility Guidance Quick Reference Guideclick here.

The Guidance memorializes the USPTO’s views in the wake of the U.S. Supreme Court rulings in 2013 in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S. Ct. 2107, and in 2012 in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289. 

In Myriad and Prometheus, the Supreme Court addressed subject matter eligibility of isolated nucleic acids and diagnostic methods, respectively, and ruled that naturally occurring things, such as the nucleic acids in Myriad, and laws of nature, such as the diagnostic methods inPrometheus, are not patent-eligible subject matter if the product is merely “isolated” or “not altered,” or if the method does not involve more than “well-understood, routine, conventional activity previously engaged in by researchers in the field.” 

While patent practitioners and the biotech industry felt the Supreme Court ignored decades of  USPTO practice in rendering the two decisions, they also were stymied in moving forward because the Court did not offer any guidance on what might be added to a claim involving a law of nature, a natural principle, a natural phenomenon or a natural product to make such claim patent-eligible – other than saying one must add “enough.”

The Guidance

In July 2012, the USPTO issued a guidance memo (click here) to its examiners instructing them to review claims for subject matter eligibility in view of Prometheus.  On June 13, 2013, the very day the Supreme Court rendered its decision in Myriad, the USPTO issued similar instructions via memorandum (click here) to its examiners to address patent eligibility in view of Myriad.  While those initial guidelines were helpful for examiners, they were less helpful for the patent practitioner as they did little more than parrot the two rulings.  The newly-issuedGuidance provides much greater help for both examiners and patent practitioners in understanding how to apply both decisions.

Effective today, March 4, 2014, all machine, composition, manufacture and process claims that recite or involve a judicial exception to patent-eligible subject matter under 35 U.S.C. 101, such as an abstract idea, a law of nature/natural principle, a natural phenomenon, and/or a natural product, should be examined using the Guidance, which superseded the June 13, 2013 Myriad memorandum, to determine whether such claim reflects a “significant difference from what exists in nature.”  If it does, it is patent-eligible.

The Guidance includes four sections.  Part I discusses the overall process for analyzing subject matter eligibility; Part II explains how to analyze “Significantly Different” from what exists in nature; Part III provides valuable examples for the patent practitioner; and Part IV provides a form paragraph to be used by an examiner rejecting a claim in accordance with theGuidance.

The overall basic process for determining subject matter eligibility under 35 U.S.C. 101 provides a straightforward set of three questions, of which the third one is the most important one in determining the outcome of the analysis: “Does the claim as a whole recite somethingsignificantly different than the judicial exception(s)?”  Having answered affirmatively the question in Part I, namely that the claim to be analyzed involves a judicial exception, theGuidance, in Part II, provides an analysis of factors that either weigh toward eligibility (significantly different) or against eligibility (not significantly different).  Those factors now likely will become the key criteria by which patent practitioners will evaluate a claim for patent eligibility, just as the Wands factor-based analysis is used to evaluate whether undue experimentation is required to make and use a claimed invention. 

The factors weighing toward patent eligibility are whether the claim recites:  

  1. Something that, after analysis, is determined to be non-naturally occurring and markedly different in structure from a naturally occurring product;
  2. Elements or steps that impose meaningful limits on the claim scope so that others are not substantially foreclosed from using the involved judicial exception(s);
  3. Elements or steps that are more than nominally, insignificantly, or tangentially related to the judicial exception(s);
  4. Elements or steps that do more than providing general instructions to apply or use the judicial exception(s);
  5. Elements or steps that include a particular machine or transformation of a particular article implementing the judicial exception(s) or integrating the judicial exception(s) into a particular application; and
  6. One or more elements or steps that add a feature that is more than well-understood, purely conventional, or routine in the relevant field.

Conversely, those factors weigh against patent eligibility if a claim recites something that involves a judicial exception and (i) is not markedly different in structure from a naturally occurring product, (ii) only includes elements or steps at a high generality such that substantially all practical limitations of the judicial exception(s) are covered, (iii) only recites elements or steps that must be used/taken by others to apply the judicial exception(s), (iv) only recites elements or steps that are well-understood, purely conventional or routine in the relevant field, (v) only recites elements or steps that are insignificant extra-solution activity, or (vi) recites elements or steps that amount to nothing more than a mere field of use.

For the life sciences patent practitioner, the most valuable part of the Guidance lies in Part III – the analysis of claims in view of the above-listed factors.  Those examples include claims encountered by many life sciences patent practitioners and are drawn to (i) plasmids, (ii) bacteria harboring plasmids, (iii) purified natural products, (iv) altered natural products, (v) method of treatment using a natural product, (vi) a manufacture of a product comprising a natural product, (vii) a composition reciting multiple natural products, (viii) nucleic acid sequences, (ix) a method of using nucleic acid sequences, (x) a method involving a natural principle and reciting a natural product, (xi) methods of treatment using a natural principle, and (xii) a method for identifying a mutant in a nucleotide sequence. 

 The Guidance provides a step-by-step analysis as to why a claim passes or fails the test for patent eligibility.  A well-versed patent practitioner should consult the Guidance carefully when drafting a patent application and claims involving a judicial exception.  Failure to do so may lead to USPTO rejection of the claim.