Today, the U.S. Patent and Trademark Office published its 2014 Interim Guidance on Patent Subject Matter Eligibility ("2014 Interim Guidance").  This Guidance supplements the June 25, 2014, Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp., and supersedes the March 4, 2014, Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products, issued in view of the Supreme Court decisions in Myriad and Mayo. 

Highlights of the New Guidance

The 2014 Interim Guidance set forth a two-part test for subject matter eligibility which is a modification of the previous guidance.

• Step 1 maintains the traditional inquiry into whether the claim defines a statutory category of eligible subject matter (a process, machine, manufacture or composition of matter).
• Step 2A determines whether the claim is directed to a judicially-recognized exception to eligible subject matter (a law of nature, a natural phenomenon, or an abstract idea). 
• Claims reciting a "nature-based product" define eligible subject matter if the nature-based product has markedly different characteristics relative to the relevant naturally-occurring counterpart.  Unlike previous guidance that was limited to an assessment of structure, markedly different characteristics may be found in structure, function, and/or properties of the nature-based product.
• Step 2B determines whether the claim amounts to significantly more than the judicial exception.  This is a subjective and fact-intensive analysis that determines whether the claim contains a meaningful limitation on, or application of, the judicial exception, or if it is solely an attempt to "tie up" the exception, even if that tying up is limited to one particular technological field.
• The Guidance also provides a new "streamlined eligibility analysis" for claims that, when viewed as a whole, clearly do not attempt to tie up any judicial exception.  The Guidance indicates that claims amenable to this abbreviated analysis should be self-evident. 

Overview of the Subject Matter Eligibility Analysis

The 2014 Interim Guidance sets forth a two-part test for subject matter eligibility illustrated in the following flowchart.

Step 1:  Statutory Categories of Patent-eligible Subject Matter

Step 1 is tied directly to the statutory language of 35 USC § 101 and asks whether the claim is directed to a "process, machine, manufacture, or composition of matter."  Answering this inquiry in the negative results in an immediate determination that of subject matter ineligibility.  This analysis has not changed relative to earlier USPTO guidance and long-standing Supreme Court jurisprudence. 

Step 2A:  Is the claim as a whole directed to a judicial exception?

Step 2A is based on the first prong of the subject matter-eligibility inquiry set forth in Mayo which asks whether the claim as a whole is directed to any one of the judicial exceptions.  The Guidelines provide that "[a] claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim."  (p. 11; emphasis added.)  Thus, to answer in the affirmative and continue with Step 2B of the analysis, an Examiner must find an explicit recitation or description in the claim of potentially ineligible subject matter.  Claims lacking such a recitation should be immediately identified as patent-eligible.  This is a significant departure from earlier USPTO guidance in which a claim was indicated for further analysis if it merely "involved" a judicial exception, even if that exception was not explicitly recited or described.

Step 2A raises a special sub-analysis for claims reciting natural products or man-made products which are based on natural products ("nature-based products").  This analysis flows directly from Myriad which held that claims to the nucleotide sequence of an isolated gene do not define patent-eligible subject matter because the claimed product does not have markedly different characteristics relative to the naturally-occurring gene.  In this inquiry, the "markedly different characteristics" analysis should be applied only to the nature-based product elements of the claim.  For nature-based products that are a combination multiple components, the analysis should be applied to the combination and not its component parts.  (p. 16.)  When there is no naturally-occurring counterpart to the nature-based product, the comparison should be made to the closest naturally occurring counterpart.  (p. 17.) 

Unlike previous USPTO guidance which was limited to only a structural analysis of the nature-based product, the 2014 Interim Guidance provides that markedly different characteristics may be based on the structure, function and/or properties.  (pp. 9 and 17-18.)  The characteristics may include biological or pharmacological functions or activities, chemical and physical properties, phenotype (including functional and structural characteristics), and structure and form (whether chemical, genetic, or physical).  (pp. 18-19.)  If a markedly different characteristic is found then the nature-based product does not define a "product of nature" and the claim is deemed patent-eligible (i.e., the answer to Step 2A is NO).  (p. 19.)  If no markedly different characteristic is found then the analysis must proceed to Step 2B.

Step 2B:  Does the claim recite significantly more than the judicial exception?

By the time the patent-eligibility inquiry reaches Step 2B, it has been determined that the claim is generally directed to a "process, machine, manufacture, or composition of matter" and that the claim affirmatively recites or describes a judicial exception.  To establish subject matter eligibility and clear the hurdle of Step 2B, the claims must recite significantly more than the judicial exception identified in Step 2A.  (pp. 20-21.)  The claim elements must be considered both individually and as an ordered combination to ensure that the claim does not monopolize the exception itself.  The 2014 Guidance fails to provide an analytical framework for performing the required analysis.  Instead, the 2014 Guidance draws extensively from Supreme Court precedent to provide examples of limitations that "may" be enough to qualify as "significantly more" and limitations that were found to be insufficient. (pp. 21-23.)  Limitations that may be enough include improvements to another technology, technical field, or to the functioning of the computer itself, applying the judicial exception with, or by use of, a particular machine, effecting a transformation a particular article to a different state or thing, and adding a specific limitation other than what is well-understood, routine, and conventional in the field.  Limitations that have found to be insufficient include, merely providing instructions to implement an abstract idea on a computer, appending well-understood, routine and conventional activities, specified at a high level of generality, to the judicial exception, adding insignificant extra-solution activity to the judicial exception (e.g., mere data gathering), and generally linking the use of the judicial exception to a particular technological environment or field of use.

Streamlined Eligibility Analysis:  Seeing the Forest for the Trees

The 2014 Interim Guidance sets forth a new and streamlined analysis for subject matter eligibility.  (pp. 24-25.)  This streamlined analysis is intended to focus the assessment on the claims as a whole and prevent some of the seemingly illogical conclusions that result from an overly rigorous element-by-element assessment.  The streamlined analysis is appropriate for claims which clearly do not seek to tie up any judicial exception such that others cannot practice it, whether or not a specific judicial exception can be specifically identified.  Here again, the 2014 Interim Guidance fails to provide a specific analytical framework but indicates that patent eligibility should be "self-evident."  Several examples are provided including (i) a claim to a robotic arm assembly having a control system that operates using certain mathematical relationships which is not an attempt to tie up use of the mathematical relationships themselves, (ii) a claim to an artificial hip prosthesis coated with a naturally occurring mineral which is not an attempt to tie up the mineral itself, (iii) a claim to a cellphone with an electrical contact made of gold or a plastic chair with wood trim which are not attempts to tie up the nature-based products themselves. 

Implications for Practitioners

The 2014 Interim Guidance provides a welcome simplification of the subject matter eligibility analysis over earlier versions of the USPTO guidance on this topic, and a renewed emphasis on assessing the claims as a whole.  The new Guidance also more closely aligns the analysis with controlling Supreme Court president and provides several notable and applicant-friendly changes. 

In particular, Step 2A now requires that the judicial exception must affirmatively recited or described in the claim to trigger further scrutiny under Step 2B.  Under previous guidance documents, additional scrutiny could be warranted if the claim merely implicated a judicial exception.  The new Step 2A guidance also provides a favorable framework to distinguish "nature-based products" from the relevant natural product.  Under this sub-analysis, a nature-based product is patent eligible if the product has markedly different characteristics compared to the natural product, and those markedly different characteristics may be based on the structure, function and/or properties of the claimed product.  Finally, the new Guidance provides a streamlined eligibility analysis for claims which, when viewed as a whole, clearly do not seek to tie up a judicial exception such that others cannot practice it.